Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the tumor. Giving thalidomide after surgery may kill any remaining tumor cells.

PURPOSE: This randomized phase II trial is studying surgery and thalidomide to see how well they work compared to surgery alone in treating patients with recurrent or metastatic colorectal cancer.

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

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Thalidomide

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