A Phase II Study of Sunitinib or Cediranib for Inoperable Metastatic Alveolar Soft Part Sarcoma

Protocol
12-095
Full Title
A Phase II Trial in Which Patients With Metastatic Alveolar Soft Part Sarcoma Are Randomized to Either Sunitinib or Cediranib Monotherapy, With Cross-Over at Disease Progression (NCI #8875)
Phase
II
Purpose

The purpose of this study is to evaluate the safety and effectiveness of the drugs sunitinib and cediranib in patients with metastatic alveolar soft part sarcoma (ASPS) which cannot be surgically removed. Patients will be randomly assigned to receive one drug or the other, but not both.

Sunitinib is approved for treating kidney cancer and gastrointestinal stroma tumor, but its use in ASPS is considered investigational. Cediranib is an investigational drug. Both drugs work by inhibiting the development of the blood vessels that tumors need to grow and spread. They are pills that are taken orally (by mouth).

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 metastatic ASPS that cannot be surgically removed.
  • At least 4 weeks must have passed since completion of prior therapies and entry into the study, and patients must have recovered from any side effects.
  • Patients may not have received prior treatment with sunitinib, cediranib, pazopanib, or sorafenib.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 16 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Mary Louise Keohan at 646-888-4160.

Disease(s)
Sarcomas
Sarcomas: Soft Tissue Sarcoma
Locations
Related Diseases