Kidney CancerPhase 2NCT00496756
Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer
A Phase 2 study testing Sorafenib in people with Kidney Cancer, run by University of Nebraska at 1 site in United States.
Trial summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2007to 25 Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed renal cell carcinoma (RCC)
- Must have a component of conventional clear cell RCC
- Predominant clear cell component ≥ 75%
- Metastatic or unresectable disease (Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or MRI)
- Measurable or nonmeasurable disease, includes any of the following:
- Small lesions, longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan
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- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonitis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Irradiated lesions, unless progression is documented after radiotherapy
- Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry staining of VEGF
- Karnofsky performance status 70-100%
- Fertile patients must use effective contraception (hormonal and/or barrier method) during and for 3 months after completion of study treatment
- Granulocyte count ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Serum bilirubin ≤ 1.5 times ULN
- Protein ≤ 1+ by urinalysis
- Creatinine ≤ 1.5 times ULN
- At least 4 weeks since prior major surgery and/or radiotherapy and recovered
- Prior palliative radiotherapy for metastatic lesion(s) allowed provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
- More than 4 weeks since prior and no other concurrent anticancer therapy
- Concurrent continuation of bisphosphonates allowed for bone metastases prophylaxis
Who cannot join
- Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors, or transitional cell carcinoma are not eligible
- No evidence of CNS metastases
- No imaging (MRI or CT scan of the brain) abnormality indicative of CNS metastases within past 42 days
- Not pregnant or nursing (negative pregnancy test)
- No ongoing hemoptysis
- No cerebrovascular accident within the past 12 months
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- No peripheral vascular disease with claudication while walking less than 1 block
- No history of clinically significant bleeding
- No deep venous thrombosis or pulmonary embolus within the past year
- No significant cardiovascular disease, defined as NYHA class II-IV congestive heart failure, angina pectoris requiring nitrate therapy, or myocardial infarction within the past 6 months
- No uncontrolled hypertension, defined as systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg while on medication
- No preexisting thyroid abnormality whose thyroid function cannot be maintained in the normal range by medication
- No uncontrolled psychiatric disorder
- No delayed healing of wounds, ulcers, and/or bone fractures
- No currently active second malignancy except nonmelanoma skin cancer (patients are not considered to have a 'currently active' malignancy if they have completed anticancer therapy and are considered by their physician to be at less than 30% risk of relapse)
- No more than one prior systemic therapy for RCC
- No prior vascular endothelial growth factor receptor agents
- No concurrent systemic corticosteroid therapy (except replacement therapy for adrenal insufficiency)
- o Topical and/or inhaled steroids allowed
- No concurrent full-dose oral or parenteral anticoagulation
- o Low-dose warfarin (1 mg) for maintenance of catheter patency or daily prophylactic aspirin allowed
- No concurrent Hypericum perforatum (St. John's wort)
- No concurrent ketoconazole, itraconazole, ritonavir, rifampin, or products containing grapefruit juice
- No concurrent hormonal therapy or chemotherapy o Concurrent hormones administered for non-disease related conditions (e.g., insulin for diabetes) allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the safety and toxicity of dose escalating sorafenib tosylate in patients with metastatic or unresectable renal cell carcinoma.
Secondary
- Determine tumor response in these patients.
- Determine time to progression in these patients.
- Determine overall survival of these patients.
Tertiary
- Collect data on angiogenesis inhibition induced by sorafenib tosylate.
- Collect data on immunomodulatory effects of sorafenib tosylate.
OUTLINE: This is an open-label study.
Patients receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients receive escalating doses of sorafenib tosylate (in the absence of grade 3 or 4 dose-limiting toxicity) until a pre-determined dose is reached.
Blood and urine samples are collected at baseline and periodically during study for VEGF level determination. Blood samples are analyzed for T4/T8, NK, CD25+, and Fox p3 by flow cytometry. Tumor tissue blocks or unstained slides are obtained for chemistry staining of VEGF.
- Conditions
- Kidney Cancer
- Being tested
- Sorafenib
- Keywords
- clear cell renal cell carcinoma, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Other | The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in following section.
Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d.
A treatment cycle will be 4 weeks.
Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol. Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity of Intrapatient Dose Escalation of Sorafenib Tosylate
To evaluate the toxicity of dose escalating sorafenib, an estimation of the percentage of patients who are unable to tolerate those escalated doses will be made. Patients will be dose escalated every 4 weeks until a maximum dose of 800 mg BID is reached.
Measured: Study completion
Secondary outcomes (1)
Response Rate
The proportion of subjects with an objective response of complete or partial based on the RECIST Criteria
Measured: from the start of the treatment until disease progression/recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study start1 Mar 2007
- Primary completion31 Oct 2009
- Study completion25 Apr 2014
Why it stopped: Low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Bayer
- Responsible party
- Sponsor
- Investigators
- Ralph Hauke, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496756
- Sponsor's protocol ID
- 0081-06-FB
- Other IDs
- P30CA036727
- Status last verified
- Oct 2023
- First submitted
- 3 Jul 2007
- Last updated
- 26 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00496756
- Acronym / sponsor ID
- 0081-06-FB
- Conditions
- Kidney Cancer
- Keywords
- clear cell renal cell carcinoma, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual rate
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Bayer
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 31 Oct 2009 (actual)
- Study completion
- 25 Apr 2014 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well sorafenib works in treating patients with metastatic or unresectable kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the safety and toxicity of dose escalating sorafenib tosylate in patients with metastatic or unresectable renal cell carcinoma.
Secondary
- Determine tumor response in these patients.
- Determine time to progression in these patients.
- Determine overall survival of these patients.
Tertiary
- Collect data on angiogenesis inhibition induced by sorafenib tosylate.
- Collect data on immunomodulatory effects of sorafenib tosylate.
OUTLINE: This is an open-label study.
Patients receive oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients receive escalating doses of sorafenib tosylate (in the absence of grade 3 or 4 dose-limiting toxicity) until a pre-determined dose is reached.
Blood and urine samples are collected at baseline and periodically during study for VEGF level determination. Blood samples are analyzed for T4/T8, NK, CD25+, and Fox p3 by flow cytometry. Tumor tissue blocks or unstained slides are obtained for chemistry staining of VEGF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Other | Drug: SorafenibThe initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in following section. Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d. A treatment cycle will be 4 weeks. Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histologically or cytologically confirmed renal cell carcinoma (RCC)
- Metastatic or unresectable disease (Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or MRI)
- Measurable or nonmeasurable disease, includes any of the following:
- Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry staining of VEGF
- Karnofsky performance status 70-100%
Key exclusion criteria (24 listed)
- Patients with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors, or transitional cell carcinoma are not eligible
- No evidence of CNS metastases
- No imaging (MRI or CT scan of the brain) abnormality indicative of CNS metastases within past 42 days
- Not pregnant or nursing (negative pregnancy test)
- No ongoing hemoptysis
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 |
|---|---|---|
| SorafenibAlso: Nexavarinitial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg | Drug | Sorafenib |
Primary outcome
Toxicity of Intrapatient Dose Escalation of Sorafenib Tosylate
Time frame: Study completion
To evaluate the toxicity of dose escalating sorafenib, an estimation of the percentage of patients who are unable to tolerate those escalated doses will be made. Patients will be dose escalated every 4 weeks until a maximum dose of 800 mg BID is reached.
1 secondary outcome
Response Rate
Time frame: from the start of the treatment until disease progression/recurrence
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ralph Hauke, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib in people with Kidney Cancer, run by University of Nebraska 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 28 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: stopped early, as of the sponsor's last update on 26 Oct 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Toxicity of Intrapatient Dose Escalation of Sorafenib Tosylate (time frame: Study completion). 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 26 Oct 2023.