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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with locally advanced or metastatic solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Calcium; Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

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