Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of recurrent or metastatic colorectal carcinoma previously resected within 12 weeks of study entry Surgical resection combined with radiofrequency ablation allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Hemoglobin at least 8.0 g/dL Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Partial thromboplastin time (PTT)/prothrombin time (PT) no greater than 120% of control (except in therapeutically anticoagulated nonrelated medical conditions [e.g., atrial fibrillation]) Total bilirubin no greater than 2.0 mg/dL (direct bilirubin no greater than 1.0 mg/dL for patients with Gilbert's syndrome) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 2.5 times normal No history of hepatic cirrhosis No concurrent hepatic dysfunction Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe congestive heart failure or active ischemic heart disease No active clots within 1 year before diagnosis OR must be receiving concurrent treatment with anticoagulant (e.g., low molecular weight heparin or equivalent agent) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for least 4 weeks before, during, and for at least 4 weeks after study participation No history of severe hypothyroidism No history of seizures No significant history of other medical problems that would preclude surgery No peripheral neuropathy greater than grade 1, except localized neuropathy due to a mechanical cause or trauma PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: See Cardiovascular No concurrent sedating drugs that cannot be reduced to a minimal level No concurrent sedating recreational drugs or alcohol No concurrent antiseizure medications
Sites / Locations
- Center for Cancer Care at Goshen Health System
- Suburban Hospital Cancer Program
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- Wake Forest University Comprehensive Cancer Center
- Charles M. Barrett Cancer Center at University Hospital
- UPMC Cancer Center at UPMC Presbyterian
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm 1 - Thalidomide once daily
Arm 2 - Placebo once daily
Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
Patients receive oral placebo once daily.