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A Phase II Study of CPT-11 and 5-FU/LCV in Patients With Previously Untreated Gastric Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer, Gastric Cancer

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Trial Information

A Phase II Study of CPT-11 and 5-FU/LCV in Patients With Previously Untreated Gastric Adenocarcinoma

OBJECTIVES: I. Determine the response rate of patients with metastatic or recurrent
adenocarcinoma of the stomach or gastroesophageal junction when treated with irinotecan,
fluorouracil, and leucovorin calcium. II. Determine the qualitative and quantitative
toxicity, and reversibility of toxicity, of this regimen in this patient population.

OUTLINE: Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV over 15
minutes, and fluorouracil IV once weekly for 4 weeks followed by 2 weeks of rest. Treatment
continues every 6 weeks in the absence of unacceptable toxicity or disease progression.
Patients are followed at 30 days, and then until death.

PROJECTED ACCRUAL: A total of 18-37 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or recurrent adenocarcinoma
of the stomach or gastroesophageal junction Bidimensionally measurable or evaluable
disease Mediastinal or hilar lymph nodes assessed by CT or MRI scan must be at least 2 cm
in diameter to be considered measurable Must not be curable with a combination of
chemotherapy and radiotherapy No brain metastases No osseous metastasis as only site of

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times
upper limit of normal No known Gilbert's syndrome Renal: Creatinine no greater than 1.5
mg/dL Calcium no greater than 12 mg/dL No symptomatic hypercalcemia under treatment Other:
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No history of seizures No serious concurrent infections or nonmalignant
medical illnesses that are uncontrolled or whose control may be jeopardized by study
complications No psychiatric disorders that would preclude study compliance No other
active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in
situ of the cervix No uncontrolled diabetes mellitus (i.e., random blood sugar less than
250 mg)

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for metastatic disease
No concurrent immunotherapy Chemotherapy: See Disease Characteristics No prior
chemotherapy for metastatic disease No prior radiosensitizing chemotherapy in metastatic
setting At least 6 months since prior adjuvant therapy No other concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4
weeks since prior radiotherapy and recovered No prior radiotherapy to major bone marrow
containing areas (e.g., pelvis, lumbar spine) No prior radiotherapy to only evaluable
lesion No concurrent radiotherapy Surgery: At least 1 week since minor surgery and 3 weeks
since major surgery and recovered Other: No concurrent phenytoin, phenobarbital, or other
antiepileptic prophylaxis No concurrent prochlorperazine on day of irinotecan
administration No other concurrent medications except for analgesics, chronic treatments
for concurrent medical conditions, or agents required for life threatening medical

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Al B. Benson, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Vanderbilt Cancer Center Nashville, Tennessee  37232-6838