Esophageal Cancer
Conditions
Keywords
stage IV esophageal cancer, recurrent esophageal cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy. Secondary * Determine the clinical benefit in patients treated with this regimen. * Determine the tolerability of this regimen in these patients. * Determine local relapse-free survival of patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30 minutes on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 1 year.
Interventions
DRUGcisplatin
DRUGfluorouracil
DRUGirinotecan hydrochloride
DRUGleucovorin calcium
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit | — |
| Tolerability | — |
| Local relapse-free survival | — |
| Overall survival | — |
Countries
France
Outcome results
None listed