Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Renal Cell Carcinoma
NCT00556205
ABOUT THIS STUDY
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- Histologically confirmed metastatic renal cell carcinoma with clear cell histology
- Patients must be off sunitinib for 14 days prior to day 1 of treatment on protocol
- Evidence of unidimensionally measurable disease based on RECIST criteria, with at least 1 measurable lesion
- Radiographic evidence of disease progression defined by RECIST during or within 6 weeks of completion of sunitinib treatment
- Participants must have received at least 14 doses of sunitinib therapy
- Participants must enroll within 3 months of the last dose of sunitinib
- Males or females, age of 18 years or older
- ECOG Performance status 0-2
- Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical procedures to NCI CTCAE version 3.0 grade 1 or less
- Laboratory values as defined in protocol
- 4 weeks or more must have elapsed from the time of major surgery and subjects must have recovered from the procedure prior to day 1 of randomization
- No anticipated need for major surgical procedure during the course of the study
- 2 weeks or more must have elapsed from the time of minor surgery and subjects must have recovered from the procedure prior to day 1 of randomization
- 4 weeks of more must have elapsed from the time of major radiotherapy prior to day 1 of randomization
- Prior treatment with bevacizumab
- Unacceptable toxicity on prior sunitinib therapy at 37.5mg or lower
- Prior systemic therapy for RCC with > 2 regimens
- Systemic therapy other than sunitinib within 4 weeks of starting the study treatment
- Uncontrolled high blood pressure
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess
within 3 months prior to day 0
- Any of the following within the 6 months prior to sudy drug administration: myocardial
infarction, severe/unstable angina, coronary/peripheral artery bypass graft,
cerebrovascular accident or transient ischemic attack, symptomatic congestive heart
failure, or ejection fraction < 30%
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range without medication
- History of or known brain metastases or spinal cord compression
- NCI CTCAE grade 2 or above hemorrhage within 4 weeks of starting study treatment
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Grade 3 or higher cardiac dysrhythmia or QT prolongation
- Concurrent use of proarrhythmic medications including terfenadine, quinidine,
procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone,
indapamide and flecainide
- Pregnancy or breastfeeding or inadequate contraception
- Significant thromboembolic event within 6 months
- Evidence of bleeding diathesis or coagulopathy
- Serious, non-healing wound, ulcer or bone fracture
- Proteinuria at screening
- Known hypersensitivity to any component of bevacizumab
- Psychiatric illness/social situation that would limit compliance with study
requirements
- Previous or concurrent malignancy requiring active systemic therapy
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Descriptive Information | |||||
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Brief Title ICMJE | Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Renal Cell Carcinoma | ||||
Official Title ICMJE | Phase II, Randomized Trial of Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Patients With Metastatic Renal Cell Carcinoma | ||||
Brief Summary | The purpose of this research study is to further define an effective strategy for people with renal cell carcinoma and to learn the safety and effectiveness of two different types of sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard treatments for advanced renal cell carcinoma. However, some people who receive this treatment do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA approved drug used for the treatment of several cancers however, is not yet approved for use in renal cell carcinoma. | ||||
Detailed Description |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Renal Cell Carcinoma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Actual Enrollment ICMJE | 0 | ||||
Original Estimated Enrollment ICMJE | 81 | ||||
Actual Study Completion Date ICMJE | September 2009 | ||||
Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00556205 | ||||
Other Study ID Numbers ICMJE | 07-202 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Dror Michaelson, MD, Massachusetts General Hospital | ||||
Study Sponsor ICMJE | Massachusetts General Hospital | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | ||||
Verification Date | March 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |