Urethral NeoplasmsPhase 1NCT01352962
Gemcitabine, Carboplatin, and Lenalidomide for Treatment of Advanced/Metastatic Urothelial Cancer and Other Solid Tumors
A Phase 1 study testing Gemcitabine, Carboplatin and Lenalidomide in people with Urethral Neoplasms and Neoplasms, Urethral, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cancers, but it has not yet… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urethral Neoplasms, Neoplasms, Urethral, Cancer of the Urethra
- What is being tested?
- Gemcitabine, Carboplatin and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2011to 6 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dose Escalation cohort only
- Adult patients with histologic documentation of an advanced solid tumor for whom gemcitabine and carboplatin would be appropriate first line therapy, including but not limited to urothelial cancer, non-small cell lung cancer, pancreatic and ovarian carcinoma.
- Expansion cohort only
- Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. Confirmation may be obtained from any CLIA certified lab.
- OR
- -Patient must have a histologically confirmed diagnosis of non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis including but not limited to squamous cell, neuroendocrine, adenocarcinoma including urachal and sarcomatoid. Confirmation may be obtained from any CLIA certified lab.
Show all 23Show fewer
- All patients
- Unresectable or metastatic disease
- Urothelial cancer patients should be ineligible for cisplatin based on one or more of the following:
- Calculated creatinine clearance of < 60 mL/min (but greater than or equal to 30 mL/min)
- Solitary kidney
- Karnofsky Performance Status < 80%
- Age greater than or equal to 18 years of age; UC is not a common cancer in children and without proven benefit, this combination of chemotherapy agents presents too great a risk for conducting as a phase I study in children.
- Karnofsky Performance Status greater than or equal to 60%
- Required Initial Laboratory Values:
- Absolute neutrophil count greater than or equal to 1.2 x 10(9)/L
- Platelets greater than or equal to 100 x 10(9)/L
- Bilirubin less than or equal to 1.5 times the upper limit of normal for the institution or less than or equal to 3 mg/dl in a subject with Gilbert Syndrome
- Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 times the ULN for the institution (less than or equal to 5 times the ULN is acceptable if liver has tumor involvement).
- Serum creatinine < 2 or calculated creatinine clearance (CrCl) greater than or equal to 30 mL/min
- Ability to understand and willingness to sign the written informed consent document.
- Patients must be able to swallow whole capsules. Capsules must not be crushed or chewed; capsules must not be opened.
- Both men and women of all races and ethnic groups are eligible for this trial.
Who cannot join
- For urothelial cancer patients, no prior combination systemic chemotherapy for metastatic disease, except:
- Single-agent radiosensitizing chemotherapy is not considered prior systemic therapy
- Prior neoadjuvant or adjuvant systemic chemotherapy (including cisplatin-based) is allowed provided it was completed greater than or equal to 6 months prior to the diagnosis of metastatic disease
- Prior intravesical therapy is permitted
- For non-urothelial cancer patients, no more than 1 prior line of combination systemic chemotherapy for metastatic disease is allowed
- Less than or equal to 2 weeks since radiation therapy
Show all 24Show fewer
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy. Patients that are on anticoagulation therapy for DVT will be allowed to enroll and continue on the treatment dose of enoxaparin or other anticoagulation such a warfarin.
- Patients with contraindications to anticoagulation therapy for deep venous thrombosis such as:
- Patients on full treatment dose of anticoagulation such as those patients being treated for a deep vein thrombosis or pulmonary embolus.
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1
- Anticipation of need for major surgical procedure during the course of the study
- Those patients that develop DVTs during the study will be treated with anticoagulants and in certain cases, will continue on the protocol.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide. Further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy. A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- Inability to comply with study and/or follow-up procedures
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide, gemcitabine or carboplatin, or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Due to the possibility of infection reactivation, patients who are known seropositive for or who have active viral infection with human immunodeficiency virus (HIV) are NOT eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Study of Gemcitabine, Carboplatin and Lenalidomide (GCL) for Treatment of Patients With Advanced/Metastatic Urothelial Carcinoma (UC) and Other Solid Tumors
Background:
- Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cancers, but it has not yet been approved for use in combination with gemcitabine and carboplatin. Researchers are interested in determining the safest and most effective dose of this combined form of chemotherapy for solid tumors, particularly for urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis).
Read more
Objectives:
- To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for solid tumor cancers.
- To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for urothelial (bladder) cancer.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatments.
- Individuals at least 18 years of age who have been diagnosed with urothelial cancer that has not responded to standard treatments.
Design:
- Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies.
- Participants with urothelial cancer will receive lenalidomide alone for the first 14 days of a 21-day cycle before starting the first full treatment cycle.
- All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1 only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the first 14 days of each cycle. Participants will be asked to take aspirin or other medications to prevent the possibility of blood clots.
- Participants may receive up to six cycles of treatment with this combination. If after six cycles the cancer has not grown or has shrunk, participants may continue to take lenalidomide alone for an additional 6 months (total of 12 months of therapy) or until the cancer recurs.
- Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment.
- After the end of the last treatment cycle, participants will have followup visits every 3 months for the next 18 months, then every 6 months for another 18 months, and then yearly.
Read the detailed description
BACKGROUND:
- Gemcitabine plus carboplatin is an accepted first-line therapy in patients unfit for cisplatin chemotherapy with metastatic urothelial carcinoma or other solid tumor malignancies.
- Both non-clinical and clinical data support targeting angiogenesis in urothelial carcinoma and other solid tumors.
- Both non-clinical and clinical data support targeting the immune system in urothelial carcinoma and other solid tumors.
- Lenalidomide has both anti-angiogenic and potent immunomodulatory properties.
- Lenalidomide has been safely coadministered with cytotoxic therapy in patients with solid tumors and non-clinical studies demonstrate possible synergy with gemcitabine.
OBJECTIVES:
Primary
- To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of lenalidomide which can be safely combined with gemcitabine and carboplatin in patients with advanced/metastatic UC and other solid tumors that are unfit for cisplatin.
Secondary
- To preliminarily evaluate the progression free survival, response rate and overall survival in patients with advanced/metastatic UC and other solid tumors treated with the combination of lenalidomide, gemcitabine, and carboplatin.
- To determine the effects of treatment on a set of 4 laboratory parameters (including Treg, sIL-2R, VEGF and CTC.) in the expansion cohort of patients with bladder cancer treated at the MTD.
ELIGIBILITY:
- Adult patients with histologic documentation of an advanced solid tumor with unresectable or metastatic disease.
- Urothelial cancer patients should be ineligible for cisplatin based on one or more of the following:
- Calculated creatinine clearance of < 60 mL/min (but greater than or equal to 30 mL/min)
- Solitary kidney
- Karnofsky Performance Status < 80%
- No prior combination systemic chemotherapy for metastatic disease allowed for patients with UC, except single agent radiosensitizing chemotherapy (not considered prior systemic therapy), or prior neoadjuvant or adjuvant systemic chemotherapy (including cisplatin-based) is allowed provided if it was completed (Bullet) 6 months prior to diagnosis of metastatic disease; or prior intravesical therapy is permitted. Up to 1 line of chemotherapy in the metastatic setting is permitted for non UC patients.
- Laboratory evaluation must meet safety requirements, including a creatinine clearance greater than 30 using the Cockroft-Gault formula; may not be pregnant or breast-feeding.
DESIGN:
- This is a single-institution phase I study of gemcitabine (1000 mg/m2 on days 1 and 8) and carboplatin (AUC 5 on day 1) plus escalating doses of lenalidomide (GCL) in patients with advanced/metastatic UC and other solid tumors ineligible for cisplatin therapy. Lenalidomide will be administered once daily on days 1 through 14 every 21 days at escalating dose. An expansion cohort at the MTD of an additional 15 patients with bladder cancer will be enrolled in order to determine whether there are differences between pre-treatment and post-treatment levels of the following parameters: Treg, sIL- 2R, VEGF and CTC.
- Patients will receive a total of 6 cycles of gemcitabine and carboplatin in combination with lenalidomide unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles will be eligible to continue lenalidomide alone at the same dose and schedule until disease progression. Restaging evaluations will occur after every 3 cycles of treatment (approximately 9 weeks).
- Based on a standard 3+3 design with 4 dose levels per cohort, a maximum of 24 patients, with the potential for an additional 3 patients with CrCl>60 mL/min, may need to be evaluated to determine the dose limiting toxicities (DLTs) and maximum tolerated dose (MTD) of lenalidomide in this combination therapy. With an expansion cohort of 15 patients at MTD, a total of 42 subjects may be enrolled over 1.5 -3 years.
- Being tested
- Gemcitabine, Carboplatin, Lenalidomide
- Keywords
- Dose Limiting Toxicity, Urethra Cancer, Carcinoma of the Bladder, Cancer of the Renal Pelvis, Ureter Cancer, Urethral Cancer, Solid Tumor, Pancreatic Cancer, Ovarian Cancer, Non-Small Cell Lung Cancer
- Medical subject headings
- Urethral Neoplasms, Urinary Bladder Neoplasms, Ureteral Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
1,000mg/m2 IVPB over 30 min x 1
CarboplatinDrug
AUC 5** IVPB over 30 min x 1
LenalidomideDrug
Escalating Doses starting at 2.5 po daily up to 25 mg po daily until MTD is reached.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Standard of Care plus escalating doses of Lenalidomide Receives: Drug: Gemcitabine; Drug: Carboplatin; Drug: Lenalidomide |
| Arm 2 | Experimental | Lenalidomide Lead for 14 days + standard of care + lenalidomide MTD Receives: Drug: Gemcitabine; Drug: Carboplatin; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose limiting toxicity (DLT)
any grade 3 or 4 toxicity with exceptions listed in protocol; MTD is one dose level below the dose that induces DLT in more than 1/6 patients
Measured: Maximum Tolerated Dose (MTD)
Secondary outcomes (4)
response rate
Percentage of patients whose cancer shrinks or disappears after treatment
Measured: every 3 months for the first 18 months, every 6 months for the subsequent 18 months, then yearly
progression free survival
time during which a patient shows no signs or symptoms of the growth or the spreading of a tumor
Measured: every 3 months for the first 18 months, every 6 months for the subsequent 18 months, then yearly
overall survival
The length of time from the start of treatment that patients are still alive
Measured: every 3 months for the first 18 months, every 6 months for the subsequent 18 months, then yearly
effects of treatment on Treg, sIL-2R, VEGF, CTC and CEC
determine the effects of treatment on a set of 5 laboratory parameters (including Treg, sIL-2R, VEGF, CTC and CEC in the expansion cohort of patients with bladder cancer treated at the MTD
Measured: baseline, lead-in day 8, lead-in day 14 and C1D8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study start26 Sep 2011
- Primary completion7 Feb 2017
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urethral NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrea B Apolo, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352962
- Sponsor's protocol ID
- 110140
- Other IDs
- 11-C-0140
- Status last verified
- 6 Aug 2026
- First submitted
- 11 May 2011
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request
Publications
Dredge K, Horsfall R, Robinson SP, Zhang LH, Lu L, Tang Y, Shirley MA, Muller G, Schafer P, Stirling D, Dalgleish AG, Bartlett JB. Orally administered lenalidomide (CC-5013) is anti-angiogenic in vivo and inhibits endothelial cell migration and Akt phosphorylation in vitro. Microvasc Res. 2005 Jan;69(1-2):56-63. doi: 10.1016/j.mvr.2005.01.002.
PubMed 15797261Corral LG, Haslett PA, Muller GW, Chen R, Wong LM, Ocampo CJ, Patterson RT, Stirling DI, Kaplan G. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol. 1999 Jul 1;163(1):380-6.
PubMed 10384139Schafer PH, Gandhi AK, Loveland MA, Chen RS, Man HW, Schnetkamp PP, Wolbring G, Govinda S, Corral LG, Payvandi F, Muller GW, Stirling DI. Enhancement of cytokine production and AP-1 transcriptional activity in T cells by thalidomide-related immunomodulatory drugs. J Pharmacol Exp Ther. 2003 Jun;305(3):1222-32. doi: 10.1124/jpet.102.048496. Epub 2003 Mar 20.
PubMed 12649301
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Gemcitabine, Carboplatin and Lenalidomide (GCL) for Treatment of Patients With Advanced/Metastatic Urothelial Carcinoma (UC) and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT01352962
- Acronym / sponsor ID
- 110140
- Keywords
- Dose Limiting Toxicity, Urethra Cancer, Carcinoma of the Bladder, Cancer of the Renal Pelvis, Ureter Cancer, Urethral Cancer, Solid Tumor, Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Sep 2011 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cancers, but it has not yet been approved for use in combination with gemcitabine and carboplatin. Researchers are interested in determining the safest and most effective dose of this combined form of chemotherapy for solid tumors, particularly for urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis).
Objectives:
- To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for solid tumor cancers.
- To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for urothelial (bladder) cancer.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatments.
- Individuals at least 18 years of age who have been diagnosed with urothelial cancer that has not responded to standard treatments.
Design:
- Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies.
- Participants with urothelial cancer will receive lenalidomide alone for the first 14 days of a 21-day cycle before starting the first full treatment cycle.
- All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1 only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the first 14 days of each cycle. Participants will be asked to take aspirin or other medications to prevent the possibility of blood clots.
- Participants may receive up to six cycles of treatment with this combination. If after six cycles the cancer has not grown or has shrunk, participants may continue to take lenalidomide alone for an additional 6 months (total of 12 months of therapy) or until the cancer recurs.
- Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment.
- After the end of the last treatment cycle, participants will have followup visits every 3 months for the next 18 months, then every 6 months for another 18 months, and then yearly.
Detailed description
BACKGROUND:
- Gemcitabine plus carboplatin is an accepted first-line therapy in patients unfit for cisplatin chemotherapy with metastatic urothelial carcinoma or other solid tumor malignancies.
- Both non-clinical and clinical data support targeting angiogenesis in urothelial carcinoma and other solid tumors.
- Both non-clinical and clinical data support targeting the immune system in urothelial carcinoma and other solid tumors.
- Lenalidomide has both anti-angiogenic and potent immunomodulatory properties.
- Lenalidomide has been safely coadministered with cytotoxic therapy in patients with solid tumors and non-clinical studies demonstrate possible synergy with gemcitabine.
OBJECTIVES:
Primary
- To establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of lenalidomide which can be safely combined with gemcitabine and carboplatin in patients with advanced/metastatic UC and other solid tumors that are unfit for cisplatin.
Secondary
- To preliminarily evaluate the progression free survival, response rate and overall survival in patients with advanced/metastatic UC and other solid tumors treated with the combination of lenalidomide, gemcitabine, and carboplatin.
- To determine the effects of treatment on a set of 4 laboratory parameters (including Treg, sIL-2R, VEGF and CTC.) in the expansion cohort of patients with bladder cancer treated at the MTD.
ELIGIBILITY:
- Adult patients with histologic documentation of an advanced solid tumor with unresectable or metastatic disease.
- Urothelial cancer patients should be ineligible for cisplatin based on one or more of the following:
- Calculated creatinine clearance of < 60 mL/min (but greater than or equal to 30 mL/min)
- Solitary kidney
- Karnofsky Performance Status < 80%
- No prior combination systemic chemotherapy for metastatic disease allowed for patients with UC, except single agent radiosensitizing chemotherapy (not considered prior systemic therapy), or prior neoadjuvant or adjuvant systemic chemotherapy (including cisplatin-based) is allowed provided if it was completed (Bullet) 6 months prior to diagnosis of metastatic disease; or prior intravesical therapy is permitted. Up to 1 line of chemotherapy in the metastatic setting is permitted for non UC patients.
- Laboratory evaluation must meet safety requirements, including a creatinine clearance greater than 30 using the Cockroft-Gault formula; may not be pregnant or breast-feeding.
DESIGN:
- This is a single-institution phase I study of gemcitabine (1000 mg/m2 on days 1 and 8) and carboplatin (AUC 5 on day 1) plus escalating doses of lenalidomide (GCL) in patients with advanced/metastatic UC and other solid tumors ineligible for cisplatin therapy. Lenalidomide will be administered once daily on days 1 through 14 every 21 days at escalating dose. An expansion cohort at the MTD of an additional 15 patients with bladder cancer will be enrolled in order to determine whether there are differences between pre-treatment and post-treatment levels of the following parameters: Treg, sIL- 2R, VEGF and CTC.
- Patients will receive a total of 6 cycles of gemcitabine and carboplatin in combination with lenalidomide unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles will be eligible to continue lenalidomide alone at the same dose and schedule until disease progression. Restaging evaluations will occur after every 3 cycles of treatment (approximately 9 weeks).
- Based on a standard 3+3 design with 4 dose levels per cohort, a maximum of 24 patients, with the potential for an additional 3 patients with CrCl>60 mL/min, may need to be evaluated to determine the dose limiting toxicities (DLTs) and maximum tolerated dose (MTD) of lenalidomide in this combination therapy. With an expansion cohort of 15 patients at MTD, a total of 42 subjects may be enrolled over 1.5 -3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gemcitabine, Drug: Carboplatin, Drug: LenalidomideStandard of Care plus escalating doses of Lenalidomide |
| Arm 2 | Experimental | Drug: Gemcitabine, Drug: Carboplatin, Drug: LenalidomideLenalidomide Lead for 14 days + standard of care + lenalidomide MTD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Dose Escalation cohort only
- Adult patients with histologic documentation of an advanced solid tumor for whom gemcitabine and carboplatin would be appropriate first line therapy, including but not limited to urothelial cancer, non-small cell lung cancer, pancreatic and ovarian carcinoma.
- Expansion cohort only
- Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. Confirmation may be obtained from any CLIA certified lab.
- OR
Key exclusion criteria (24 listed)
- For urothelial cancer patients, no prior combination systemic chemotherapy for metastatic disease, except:
- Single-agent radiosensitizing chemotherapy is not considered prior systemic therapy
- Prior neoadjuvant or adjuvant systemic chemotherapy (including cisplatin-based) is allowed provided it was completed greater than or equal to 6 months prior to the diagnosis of metastatic disease
- Prior intravesical therapy is permitted
- For non-urothelial cancer patients, no more than 1 prior line of combination systemic chemotherapy for metastatic disease is allowed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine1,000mg/m2 IVPB over 30 min x 1 | Drug | Arm 1, Arm 2 |
| CarboplatinAUC 5** IVPB over 30 min x 1 | Drug | Arm 1, Arm 2 |
| LenalidomideEscalating Doses starting at 2.5 po daily up to 25 mg po daily until MTD is reached. | Drug | Arm 1, Arm 2 |
Primary outcome
dose limiting toxicity (DLT)
Time frame: Maximum Tolerated Dose (MTD)
any grade 3 or 4 toxicity with exceptions listed in protocol; MTD is one dose level below the dose that induces DLT in more than 1/6 patients
4 secondary outcomes
response rate
Time frame: every 3 months for the first 18 months, every 6 months for the subsequent 18 months, then yearly
progression free survival
Time frame: every 3 months for the first 18 months, every 6 months for the subsequent 18 months, then yearly
overall survival
Time frame: every 3 months for the first 18 months, every 6 months for the subsequent 18 months, then yearly
effects of treatment on Treg, sIL-2R, VEGF, CTC and CEC
Time frame: baseline, lead-in day 8, lead-in day 14 and C1D8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 15797261Dredge K, Horsfall R, Robinson SP, Zhang LH, Lu L, Tang Y, Shirley MA, Muller G, Schafer P, Stirling D, Dalgleish AG, Bartlett JB. Orally administered lenalidomide (CC-5013) is anti-angiogenic in vivo and inhibits endothelial cell migration and Akt phosphorylation in vitro. Microvasc Res. 2005 Jan;69(1-2):56-63. doi: 10.1016/j.mvr.2005.01.002.
- Background: PubMed 10384139Corral LG, Haslett PA, Muller GW, Chen R, Wong LM, Ocampo CJ, Patterson RT, Stirling DI, Kaplan G. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol. 1999 Jul 1;163(1):380-6.
- Background: PubMed 12649301Schafer PH, Gandhi AK, Loveland MA, Chen RS, Man HW, Schnetkamp PP, Wolbring G, Govinda S, Corral LG, Payvandi F, Muller GW, Stirling DI. Enhancement of cytokine production and AP-1 transcriptional activity in T cells by thalidomide-related immunomodulatory drugs. J Pharmacol Exp Ther. 2003 Jun;305(3):1222-32. doi: 10.1124/jpet.102.048496. Epub 2003 Mar 20.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea B Apolo, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine, Carboplatin and Lenalidomide in people with Urethral Neoplasms and Neoplasms, Urethral, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose limiting toxicity (DLT) (time frame: Maximum Tolerated Dose (MTD)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01352962, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.