Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
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|ClinicalTrials.gov Identifier: NCT00165217|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 21, 2007
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Adenocarcinoma||Drug: Capecitabine Drug: Thalidomide||Phase 2|
- 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 the treatment.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
- To assess the anti-tumor activity of capecitabine and thalidomide when administered to patients with previously treated metastatic colorectal cancer.
- To evaluate the safety of capecitabine and thalidomide in this patient population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165217
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Charles S. Fuchs, MD, MPH||Dana-Farber Cancer Institute|