Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal Carcinoma
Completed · Phase 2
Conditions studied: Colorectal Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT00165217
- Run by
- Dana-Farber Cancer Institute
- People needed
- 37
- Starts
- 2001-11-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2007-12-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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