Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Capecitabine; Thalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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