Phase 2
N=69
Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer
Chromophobe Renal Cell Carcinoma · Clear Cell Renal Cell Carcinoma · Papillary Renal Cell Carcinoma · Recurrent Renal Cell Carcinoma · Sarcomatoid Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00126503 ↗Enrolled (actual)
69
Serious AEs
36.2%
Results posted
Jun 2013
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I) — 200 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Biological); Sorafenib Tosylate (Drug); Pharmacological Study (Other); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I) |
200 | — |
| PRIMARY Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I) |
5 | — |
| PRIMARY Objective Response |
0; 0; 23; 3; 2; 0 | — |
| SECONDARY Overall Survival |
24; 25 | — |
| SECONDARY Progression-free Survival |
11; 15 | — |
Summary
This phase I/II trial studies the side effects and best dose of sorafenib tosylate and bevacizumab and to see how well they work in treating patients with advanced kidney cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth by targeting certain cells. Bevacizumab and sorafenib tosylate may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib tosylate together with bevacizumab may kill more tumor cells.
Eligibility Criteria
Inclusion Criteria
- PHASE I ELIGIBILITY CRITERIA
- Patients must have histological or cytological confirmation of renal cell carcinoma (clear cell, papillary, chromophobe, or sarcomatoid) not curable by standard approaches; tumor must be measurable by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; nephrectomy prior to enrollment is not required
- Patients may not have had prior therapy with inhibitors of the mitogen-activated protein (MAP) kinase pathway or inhibitors of VEGF and/or its receptor signaling (VEGFR2)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of greater than 3 months
- Hemoglobin (Hgb) >= 9.0gm/dl (transfusions allowed prior to enrollment)
- White Blood Count >= 3,000/mm^3
- Absolute Granulocyte Count >= 1,200/mm^3
- Platelet Count >= 100,000/mm^3
- Serum creatinine = = 40ml/min (neither drug is cleared by the kidney)
- Total Bilirubin = 30% of liver parenchymal) or multiple (> 5) bone metastases, or extensive extrarenal tumor or unresectable local/regional tumor extension making nephrectomy a clinically questionable and unreasonable procedure
- For the phase II study, patients will be allowed no more than one prior regimen containing a vaccine or cytokine based immunotherapy or chemotherapy for advanced disease
- Hgb >= 9.0gm/dl (transfusions allowed prior to enrollment)
- White Blood Count >= 3, 000/mm^3 (phase II)
- Absolute Granulocyte Count >= 1, 200/mm^3 (phase II)
- Platelet Count >= 100,000/mm^3 (phase II)
- Serum creatinine = = 40ml/min (neither drug is cleared by the kidney) (phase II)
- Total Bilirubin = 1000 mg protein/24 hours ) at baseline; subjects discovered to have >= 1+ proteinuria on dipstick should undergo a 24-hour urine collection, which should contain < 1000 mg protein/ 24 hours to be allowed participation in the study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients taking cytochrome P450 enzyme-inducing antiepileptic drugs will be excluded (phenytoin, carbamazepine, Phenobarbital, rifampin, and St.John's Wort)
- Pregnant and lactating women are excluded from the study; breastfeeding should be discontinued while receiving therapy
- Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study
Data sourced from ClinicalTrials.gov (NCT00126503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.