At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed unresectable and/or metastatic renal cell carcinoma (excluding collecting duct, oncocytoma, transitional cell; sarcomatoid RCC allowed)
- ✓Measurable disease: ≥20 mm on conventional imaging or ≥10 mm on spiral CT
- ✓Up to 1 prior immunotherapy regimen (IL-2 or interferon-alpha) ending ≥4 weeks before enrollment
- ✓Up to 2 prior regimens of MAPK/VEGF pathway inhibitors (e.g. sunitinib, bevacizumab) or mTOR inhibitors (e.g. temsirolimus) ending ≥4 weeks before enrollment
- ✕Prior chemotherapy; must have ≥4 weeks recovery from prior definitive surgery or radiation therapy
- ✕Known active brain metastases
- ✕Prior treatment with sorafenib
- ✕History of allergic reactions to sorafenib, gemcitabine, or capecitabine or chemically/biologically similar compounds
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial of BAY 43-9006 Plus Gemcitabine and Capecitabine in the Treatment of Patients With Advanced Renal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Capecitabine, Gemcitabine Hydrochloride, and 1 other intervention for Recurrent Renal Cell Carcinoma and 2 related conditions. Completed, enrolled 17 participants across 4 sites.
Detailed Summary
This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine, and capecitabine and to see how well they work in treating patients with unresectable and/or metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with gemcitabine and capecitabine may kill more tumor cells.
Study Details
Timeline
Interventions
Given PO
Given IV
Given PO