NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility 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
Sites / Locations
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center, UCLA