NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer

You may be eligible if

• 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