Study on Sorafenib for Treating Gastrointestinal Stromal Tumors After Previous Treatments
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00265798
This clinical trial is testing how well the drug Sorafenib works for patients with gastrointestinal stromal tumors that have not responded to previous treatments with Imatinib and Sunitinib. Sorafenib may help by blocking tumor growth and cutting off blood supply to the tumor.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring the effectiveness of Sorafenib in treating patients with gastrointestinal stromal tumors that have continued to grow despite previous treatments with Imatinib and Sunitinib. Sorafenib works by blocking certain enzymes and blood flow that tumors need to grow. The trial aims to see how well Sorafenib can shrink tumors, how long patients can live without the disease getting worse, and overall survival rates. Researchers will also look at whether specific genetic mutations in the tumors affect how well Sorafenib works.
Description
The main goal of this study is to find out how well Sorafenib works in shrinking tumors in patients whose gastrointestinal stromal tumors have not responded to previous treatments with Imatinib and Sunitinib. Researchers will also monitor any side effects patients experience while taking Sorafenib and how long patients live without the disease getting worse. Additionally, the study will explore if certain genetic mutations in the tumors affect the response to Sorafenib.
Patients will take Sorafenib pills twice a day in 28-day cycles. The treatment will continue as long as the disease does not progress and side effects are manageable. After finishing the treatment, patients will have regular follow-up visits to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with gastrointestinal stromal tumor that cannot be cured with surgery.
- Tumor must express a specific protein called Kit.
- Tumor must have grown despite treatment with Imatinib and Sunitinib.
- Must have at least one tumor that can be measured by scans.
- No known spread of cancer to the brain.
- Must be in relatively good health with a performance status score between 0 and 2.
- Must have adequate blood cell counts and organ function as determined by specific blood tests.
- Must not have severe heart conditions or uncontrolled high blood pressure.
- Women must not be pregnant or breastfeeding and must agree to use effective birth control.
- No other cancers in the past 5 years, except for certain skin or cervical cancers.
- No allergies to Sorafenib or similar drugs.
- No active infections or psychiatric conditions that would prevent participation.
- Must not have had certain treatments or medications recently, including other cancer therapies or specific drugs that affect liver enzymes.
- Must not be taking certain medications for epilepsy or herbal supplements like St. John's wort.
- HIV-positive patients must not be on certain antiviral therapies.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| Decatur Memorial Hospital | 62526 | Decatur | Illinois |
| Central Illinois Hematology Oncology Center | 62702 | Springfield | Illinois |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.