Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: thalidomide; adjuvant therapy; Placebo
Intervention description: 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).; Initial dose: 100 mg by mouth (po) every bedtime ( Q hs) for four weeks, then progress to 200 mg po Q hs for four weeks, then progress to maintenance dose: 300 mg po Q hs.; oral placebo once daily
Intervention MeSH terms: Thalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

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.
    

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