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A Phase II Trial of Sorafenib and Dacarbazine in Soft-Tissue Sarcoma
[Protocol 08-068]
- Full Title :
- PHASE II TRIAL OF SORAFENIB AND DACARBAZINE IN SOFT TISSUE SARCOMA
- Purpose :
Recurrent sarcoma is difficult to treat. Standard chemotherapy drugs can be cause side effects, and the length of benefit is usually short. As a result, doctors are seeking new treatments for sarcoma. The purpose of this study is to evaluate the safety and effectiveness of combining the drugs sorafenib and dacarbazine in patients with leiomyosarcoma, synovial sarcoma, or malignant peripheral nerve sheath tumor that cannot be surgically removed or has spread to other parts of the body.
Sorefanib (Nexavar®) is already approved for the treatment of renal cell carcinoma and liver cancer. It works by stopping a signal made by cancer cells, which they need to multiply and grow, and through inhibiting blood supply to cancer cells. Sorafenib is a capsule that is taken by mouth.
Dacarbazine is a standard chemotherapy drug used to treat sarcoma. It is given intravenously.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of leiomyosarcoma, synovial sarcoma, or malignant peripheral nerve sheath tumor that cannot be surgically removed or has spread to other parts of the body.
- At least 3 weeks must have passed since completion of prior chemotherapy and entry into the study. Patients may not have had more than two prior regimens of chemotherapy.
- Patients may not have previously received dacarbazine, sorafenib, or other anti-angiogenic agents.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. David D'Adamo at 212-639-7573.
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