A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
- Patients will take capecitabine orally twice a day for two weeks followed by a one week
break period. These three week cycles will continue as long as the patient continues
to benefit from the the therapy and does not experience intolerable side effects.
- Thalidomide will be taken orally once daily in the evening. Each week teh daily dose
of the medication will be increased by 100mg as long as the patient is not experiencing
any moderate to severe side effects. The dose will be increased in this manner until
the daily dose is 600mg. If side effects do develop, the dose will either be held
constant or decreased until the side effects resolve. If the side effects do not
resolve, treatment will be stopped.
- Before starting treatment and periodically throughout the study, a physical exam,
routine blood tests, scans and x-rays will be done to monitor the body's response to
- For women patients, pregnancy tests will be performed every 3 weeks while on therapy.
- Scans and x-rays will be performed every 9 weeks (after every 3 cycles of treatment) to
follow the effects of the study drugs on the tumor.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer.
Charles S. Fuchs, MD, MPH
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|