Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced or metastatic solid tumor

  • Refractory to standard therapy or for which there is no standard therapy
  • Preference given to colorectal cancer, upper gastrointestinal cancer, or neuroendocrine tumors
• Evaluable disease
• No CNS metastases or primary CNS malignancy
• Performance status - Karnofsky 60-100%
• WBC at least 3,500/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Creatinine no greater than 1.5 mg/dL
• No history of cardiac arrhythmia
• No congestive heart failure
• No myocardial infarction within the past 6 months
• No prior grade 3 or 4 diarrhea secondary to irinotecan, despite optimal antidiarrheal prophylaxis
• HIV negative
• No serious or uncontrolled infection
• No other medical condition or reason that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 2 months after study participation
• At least 2 weeks since prior immunotherapy
• No more than 2 prior chemotherapy regimens unless there is no evidence of significant myelotoxicity as determined by the primary investigator
• At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin)
• Prior irinotecan and fluorouracil allowed
• At least 2 weeks since prior radiotherapy
• Recovered from all prior therapy
• No other concurrent investigational medications
• No concurrent vitamins, antioxidants, or herbal preparations or supplements except a single daily multivitamin