A Multicenter, Phase II, Randomized, Blinded, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Sutent With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Genentech, Inc.
- Enrollment
- 16
- Primary Endpoint
- All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
Brief Summary
This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo with sunitinib in patients with metastatic RCC who have not received prior systemic therapy for metastatic disease. The study will enroll approximately 100 patients at approximately 20 centers in the United States.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent Form
- •Histologically confirmed metastatic RCC
- •Measurable disease, as defined by RECIST
- •Age ≥ 18 years
- •ECOG performance status of 0 or 1
- •Prior nephrectomy
- •Ability and capacity to comply with study and follow-up procedures
Exclusion Criteria
- •RCC with predominantly sarcomatoid features
- •Prior systemic or adjuvant therapy for RCC
- •Radiotherapy for RCC within 28 days prior to Day 1
- •Prior treatment with bevacizumab, sunitinib, sorafenib, axitinib, thalidomide, or other similar agents
- •Current need for dialysis
- •Life expectancy of \< 12 weeks
- •Current, recent, or planned participation in an experimental drug study
- •Inadequate organ function
- •Active infection or fever \> 38.5°C within 3 days of starting treatment
- •History of other malignancies within 5 years prior to Day 1
Arms & Interventions
1
Intervention: bevacizumab
1
Intervention: sunitinib
2
Intervention: sunitinib
2
Intervention: placebo
Outcomes
Primary Outcomes
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Time Frame: 5 months
Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.