Clinical trial NCT00019747 (phase 2, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: thalidomide
SMILES: CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Reason stopped: 
    dsmb recommended closure of the protocol due to slow accrual.
  
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