Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
18 Years
75 Years
Both
Esophageal Cancer
Trial Information
Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate
Safety Issue:
No
Principal Investigator
Pascal Artru, MD
Investigator Affiliation:
Clinique Saint Jean
Authority:
United States: Federal Government
Study ID:
CDR0000349275
NCT ID:
NCT00075738
Start Date:
October 2003
Completion Date:
Related Keywords:
- Esophageal Cancer
- stage IV esophageal cancer
- recurrent esophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms
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