Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00415116
Lenalidomide, Docetaxel, and Carboplatin in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing carboplatin, docetaxel and lenalidomide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The Cleveland Clinic.
Trial summary
RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- carboplatin, docetaxel and lenalidomide
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Jul 2007
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven solid tumor
- Measurable or evaluable disease
- Refractory to standard treatment
- No prior failure of a docetaxel and carboplatin regimen except in the adjuvant setting
- History of brain disease allowed, provided the following criteria are met:
- Brain disease previously treated with radiotherapy or surgery
- Asymptomatic with no active brain disease, as documented by CT scan or MRI, for at least 3 months
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 mg/dL
- Bilirubin normal
- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
- Alkaline phosphatase ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
- No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent, expose the patient to unacceptable risk, or affect the interpretation of study data
- No known hypersensitivity to thalidomide
- No history of erythema nodosum, characterized by a desquamating rash, while taking thalidomide or similar drugs
- No pre-existing peripheral neuropathy ≥ grade 2
- No known hypersensitivity or intolerance to taxanes
- No known HIV positivity
- No known infectious hepatitis, types A, B, or C
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 2 prior chemotherapy regimens
- At least 28 days since prior cancer therapy, including radiotherapy, biologic therapy, hormonal therapy, chemotherapy, or surgery
- At least 28 days since any other prior investigational drug or therapy
- No prior lenalidomide
- No other concurrent chemotherapy or biologic therapy
- No concurrent radiotherapy
- No concurrent use of any other anticancer agents or treatments
- No prophylactic granulocyte colony-stimulating factors (G-CSF) during the first course of study treatment
- No concurrent prophylactic antibiotics
- No concurrent treatment with the following medications:
- Systemic corticosteroids (except as prophylaxis for docetaxel administration)
- Estrogens
- Azoles
- Macrolides
- Cyclosporine
- Rifampin
- Phenytoin
About this study
Official title: Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors
RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel and carboplatin in treating patients with advanced solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of lenalidomide when administered with docetaxel and carboplatin in patients with advanced solid tumors.
Secondary
- Determine the safety and toxic effects of this regimen in these patients.
- Determine, preliminarily, the clinical activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of lenalidomide.
Patients receive docetaxel IV over 1 hour followed by carboplatin IV on day 1. Patients also receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of 6 courses of treatment may continue lenalidomide alone once daily on days 1-14. Patients whose disease is stable or responding after completing 2 or 4 courses and who are unable to tolerate further chemotherapy may continue lenalidomide alone once daily on days 1-14, at the investigator's discretion. Treatment with lenalidomide repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6-8 patients are treated at the MTD.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
- Being tested
- carboplatin, docetaxel, lenalidomide
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
docetaxelDrug
lenalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of lenalidomide
Dose-limiting toxicity of lenalidomide
Secondary outcomes (2)
Safety and toxicity
Clinical activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startAug 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Tarek M. Mekhail, MD, Study chair, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415116
- Sponsor's protocol ID
- CASE-CCF-7216
- Other IDs
- P30CA043703, CASE-CCF-7216
- Status last verified
- Nov 2006
- First submitted
- 21 Dec 2006
- Last updated
- 8 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00415116
- Acronym / sponsor ID
- CASE-CCF-7216
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Dec 2006 (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.
RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel and carboplatin in treating patients with advanced solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of lenalidomide when administered with docetaxel and carboplatin in patients with advanced solid tumors.
Secondary
- Determine the safety and toxic effects of this regimen in these patients.
- Determine, preliminarily, the clinical activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of lenalidomide.
Patients receive docetaxel IV over 1 hour followed by carboplatin IV on day 1. Patients also receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of 6 courses of treatment may continue lenalidomide alone once daily on days 1-14. Patients whose disease is stable or responding after completing 2 or 4 courses and who are unable to tolerate further chemotherapy may continue lenalidomide alone once daily on days 1-14, at the investigator's discretion. Treatment with lenalidomide repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6-8 patients are treated at the MTD.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| carboplatin | Drug | – |
| docetaxel | Drug | – |
| lenalidomide | Drug | – |
Primary outcome
Maximum tolerated dose of lenalidomide
Dose-limiting toxicity of lenalidomide
2 secondary outcomes
Safety and toxicity
Clinical activity
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 8 Jul 2011.
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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.
Tarek M. Mekhail, MD study chair
Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing carboplatin, docetaxel and lenalidomide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Maximum tolerated dose of lenalidomide. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2011.