This trial is active, not recruiting.

Condition esophageal cancer
Treatments cisplatin, fluorouracil, irinotecan hydrochloride, leucovorin calcium
Phase phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date October 2003
Trial identifier NCT00075738, CDR0000349275, EU-20328, FRE-GERCOR-D00-2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Objective response rate
time frame:

Secondary Outcomes

Clinical benefit
time frame:
time frame:
Local relapse-free survival
time frame:
Overall survival
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).