Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Calcium; Camptothecin; Cisplatin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed esophageal cancer

• Metastatic disease

• At least 1 unidimensionally measurable metastatic lesion

• At least 10 mm by spiral scanner OR 20 mm by sequential scanner

• Outside the field of prior radiotherapy

• No known symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

• Bilirubin ≤ 1.5 times normal

• Alkaline phosphatase ≤ 3 times normal (5 times normal if liver metastases are present)

• SGOT and SGPT ≤ 3 times normal

Renal

• Creatinine ≤ 1.5 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months

• No uncontrolled angina

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

• No other illness or medical condition that would preclude study participation

• No psychological, social, familial, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 6 months since prior fluorouracil and/or cisplatin

• No other prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• More than 6 weeks since prior radiotherapy

Surgery

• More than 4 weeks since prior surgery

Other

• No concurrent participation in another clinical study