Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors

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

Summary

RATIONALE: 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.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced solid tumor that has failed standard therapy or for which no standard therapy exists

• Locally advanced, unresectable, primary or recurrent disease OR

• Metastatic disease

• Previously untreated disease allowed provided this regimen represents reasonable first-line therapy

• No leukemia or lymphoma

• No primary CNS malignancy or CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.6 mg/dL

• AST/ALT no greater than 4 times upper limit of normal

Renal:

• Creatinine no greater than 1.6 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No other serious concurrent illness that would preclude study

• No active infection requiring IV antibiotics

• No known hypersensitivity to irinotecan

• No marked intolerance to fluorouracil

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• More than 4 weeks since prior immunotherapy and recovered

Chemotherapy:

• More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered

• Prior short-infusion irinotecan allowed

• Prior fluorouracil allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 2 weeks since prior radiotherapy and recovered

• At least 8 weeks since prior strontium chloride Sr 89

Surgery:

• Recovered from prior surgery

Other:

• No concurrent cimetidine