Status:
COMPLETED
Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Colorectal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to collect information about the antitumor activity and the safety of capecitabine and thalidomide in patients with colorectal cancer.
Detailed Description
* 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 t...
Eligibility Criteria
Inclusion
- Histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage IV (metastatic) disease
- Measurable tumor
- Serum creatinine \< 1.5 mg/dl
- Total bilirubin \< 2.0 mg/dl
- AST \< 5 x ULN
- ANC \> 1,500/mm3
- Platelets \> 100,000/mm3
- Hemoglobin \> 9.0 gm/dl
- Must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. At least 3 weeks must have passed since the last chemotherapy treatment
- 18 years of age or older
- ECOG performance status of less than or equal to 2
- Life expectancy of greater than 12 weeks
Exclusion
- Prior treatment with mitomycin C or nitrosourea compounds
- Prior treatment with capecitabine or thalidomide
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Peripheral neuropathy of grade 2 or greater severity
- Myocardial infarction in the past 6 months
- Major surgery in the past 2 weeks
- Uncontrolled serious medical or psychiatric illness
- Pregnant or lactating women
- Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Known allergy to 5-FU
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00165217
Start Date
November 1 2001
End Date
December 1 2005
Last Update
December 21 2007
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115