Name of the Trial Phase II Study of Cediranib (AZD2171) in Patients with Alveolar Soft Part Sarcoma (NCI-09-C-0192). See the protocol summary .
Dr. Shivaani Kummar
Principal Investigator Dr. Shivaani Kummar, NCI Center for Cancer Research
Why This Trial Is Important Alveolar soft part sarcoma (ASPS) is an extremely rare type of soft-tissue sarcoma that typically affects teenagers and young adults. It usually develops in the muscles or deep soft tissue of the legs, but it can also arise in the trunk of the body, the head and neck region, and the arms. ASPS is a slow-growing cancer, and it often does not produce symptoms until it has reached an advanced stage. Consequently, the long-term outlook for patients with this type of cancer is poor.
Surgery is the most effective treatment for ASPS, but many patients have widespread metastatic disease by the time they are diagnosed and are not candidates for surgical treatment. In addition, chemotherapy regimens that have been used to treat other types of soft tissue sarcoma are not effective in patients with ASPS. There is no currently accepted standard of care for advanced ASPS.
Cediranib is an experimental drug that blocks the activity of a number of proteins important to the growth of new blood vessels to tumors, a process known as tumor angiogenesis . Because ASPS tumors are highly angiogenic, doctors want to know if cediranib would be effective in slowing or stopping their growth. In early trials of the drug , patients with ASPS showed some partial responses or disease stabilization. Based on these findings, researchers at NCI are conducting a phase II clinical trial of cediranib in ASPS patients.
In this trial, patients with metastatic ASPS will be treated with cediranib by mouth once a day in 28-day cycles until disease progression or unacceptable toxicity. Doctors will monitor patients for signs of tumor shrinkage and possible side effects of treatment.
“Cediranib is showing preliminary activity in this disease, and, given that no other systemic treatment is effective, I think cediranib presents an option for these patients,” said Dr. Kummar. “In order to evaluate the drug further in this disease, we’ve expanded the trial to enroll more patients.”
Once accepted into the study, patients will visit the NIH Clinical Center every 2 to 4 weeks for examination and to receive the study medication. Travel assistance may be available.