At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic or unresectable renal cell cancer with clear cell component (excluding pure papillary, sarcomatoid without clear cell, chromophobe, oncocytoma, collecting duct, and transitional cell)
- ✓Measurable disease: ≥1 lesion ≥2.0 cm by conventional techniques or ≥1.0 cm by spiral CT
- ✓Tumor tissue available and patient willing to donate blood for research (phase II only)
- ✓ECOG performance status 0-2
- ✕CNS metastases by head CT or MRI
- ✕Significant cardiovascular disease: NYHA class II-IV heart failure, angina requiring nitrates, myocardial infarction within 6 months, uncontrolled hypertension (SBP ≥160 or DBP ≥90 despite medication), cardiac arrhythmias, or other significant cardiovascular disease
- ✕Cerebrovascular accident within 6 months or peripheral vascular disease with claudication on <1 block
- ✕Ongoing hemoptysis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial of CCI-779 and Bevacizumab in Stage IV Renal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating CCI-779 and Bevacizumab for Clear Cell Renal Cell Carcinoma and 2 related conditions. Completed, enrolled 60 participants across 2 sites.
Detailed Summary
This phase I/II trial is studying the side effects and best dose of CCI-779 and bevacizumab and to see how well they work in treating patients with metastatic or unresectable kidney cancer. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving CCI-779 together with bevacizumab may kill more tumor cells.
Study Details
Timeline
Interventions
CCI-779 is taken IV on days 1, 8, 15, 22 of a 28-day cycle. Dose level is dependent on phase.
Bevacizumab is taken IV on Days 1 and 15 of a 28-day cycle. Dose Level determined by phase.