NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer

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