NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed metastatic or recurrent colorectal adenocarcinoma that has progressed during or within 6 months of fluoropyrimidine-based therapy
• •Prior treatment with irinotecan with or without fluorouracil
• •Evaluable or measurable disease
• •* Uni-dimensionally measurable disease allowed provided CEA is at least 2 times the upper limit of normal
• •No meningeal or CNS metastases or carcinomatous meningitis
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •Karnofsky 70-100%
• •Life expectancy:
• •At least 3 months
• •Hematopoietic:
• •WBC at least 3,000/mm\^3
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Bilirubin less than 1.5 mg/dL (regardless of liver metastases)
• •AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present)
• •PT and INR normal
• •PTT normal
• •Renal:
• •Creatinine less than 1.5 mg/dL OR
• •Creatinine clearance greater than 50 mL/min
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •HIV negative
• •No known hypersensitivity to NB1011 or any excipient or vehicle in its formulation
• •No active or uncontrolled serious bacterial, viral, fungal, or parasitic infection
• •No prior or concurrent alcohol abuse or dependency
• •No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• •No concurrent medical or psychological condition that would preclude study
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •See Disease Characteristics
• •Recovered from prior anticancer chemotherapy
• •No concurrent fluoropyrimidine-based or thymidylate synthase inhibitor agents
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •Recovered from prior anticancer radiotherapy
• •No concurrent radiotherapy except palliative radiotherapy (to control a fracture or pain) provided index lesions are not involved
• •Surgery:
• •Recovered from prior anticancer surgery
• •Other:
• •At least 30 days since prior investigational agents
• •No other concurrent anticancer therapy
• •No concurrent disulfiram