Breast Cancer Clinical Trial
Official title:
Phase I Study of Sorafenib, Pemetrexed, and Cisplatin for the Treatment of Advanced Solid Tumors.
RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by
blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, 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 pemetrexed and cisplatin may kill more
tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when
given together with pemetrexed and cisplatin in treating patients with advanced solid tumors.
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of sorafenib tosylate when given in combination
with pemetrexed disodium and cisplatin in patients with advanced non-squamous cell solid
tumor malignancy including, but not limited to, breast, lung, colon, pancreatic,
prostate, or head and neck cancer or sarcoma.
Secondary
- To characterize the quantitative and qualitative toxicities of this regimen in these
patients.
- To obtain preliminary information about the antitumor activity of this regimen in these
patients.
OUTLINE: This is a dose-escalation study of sorafenib tosylate.
Patients receive oral sorafenib tosylate once daily on days 1-21 and cisplatin IV over 1-2
hours and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days, every 8 weeks until
disease progression, and then every 3 months for up to 6 months.
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