Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
- Conditions
- Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT00631371
- Lead Sponsor
- Pfizer
- Brief Summary
Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 791
- Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
- Majority component of conventional clear-cell type is mandatory
- At least 1 measurable lesion (per RECIST)
- Prior systemic treatment for RCC
- Evidence of current or prior central nervous system (CNS) metastases
- Cardiovascular disease
- Pregnant or nursing women
- Additional criteria applies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Interferon-Alfa 9MU Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW 1 Temsirolimus Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly 1 Bevacizumab Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly 2 Bevacizumab Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS): Independent-Assessment Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS): Investigator-Assessment Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Overall Survival (OS) Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012) OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Trial Locations
- Locations (169)
Hematology Oncology Services of Arkansas
🇺🇸Little Rock, Arkansas, United States
South County Hematology/Oncology
🇺🇸Chula Vista, California, United States
Cancer Center Oncology Medical Group
🇺🇸La Mesa, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
UCLA
🇺🇸Los Angeles, California, United States
North County Oncology Medical Clinic
🇺🇸Oceanside, California, United States
Medical Oncology Associates - SD
🇺🇸San Diego, California, United States
Sharp Memorial Hospital Investigational Pharmacy
🇺🇸San Diego, California, United States
Sharp Rees-Stealy
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
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