Irinotecan in Treating Patients With Esophageal or Stomach Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer.

Detailed Description
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OBJECTIVES: I. Determine the antitumor activity of irinotecan in patients with adenocarcinoma of the esophagus or gastric cardia. II. Evaluate the toxicities of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive irinotecan intravenous (IV) over 90 minutes once a week for 4 weeks followed by a 2 week rest period. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.

Official Title
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Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be > 18 years of age Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale Patients must have a predicted life expectancy of at least 12 weeks Patients must have a pretreatment granulocyte count of >1500/mm3, a hemoglobin level of >9.0 gm/dL and the platelet count of >100000/mm3 Patients must have adequate renal function as documented by a serum creatinine < 2.0 mg/dL Patients must have adequate hepatic function as documented by a serum bilirubin < 1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase must be < 3 x institutional upper limit of normal unless the liver is involved with tumor, in which case the aspartate transaminase must be < 5 x institutional upper limit of normal Patients must have histologically proven adenocarcinoma of the esophagus or gastric cardia with progression despite prior chemotherapy Patients must have disease radiologically measurable bidimensionally Patients must have an interval of 4 weeks from prior chemotherapy, immunotherapy, or radiation therapy Exclusion Criteria: Patients with any active or uncontrolled infection Patients with psychiatric disorders that would interfere with consent or follow-up Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method Presence of clinically apparent central nervous system metastases or carcinomatous meningitis Patients with uncontrolled diabetes mellitus Patients with any other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study Prior therapy with a deoxyribonucleic acid (DNA) topoisomerase inhibitor Patients with known Gilbert's syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: irinotecan hydrochloride<br>One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks. | Drug: irinotecan hydrochloride<br>* One course of therapy is comprised of a 4-week treatment period and a two-week rest period. Drug administration will be based on actual calculated body surface area. Starting dose will be 125 mg/m2/day given once per week on four consecutive weeks.<br>* Other names: CPT-11;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the antitumor activity of irinotecan hydrochloride (CPT-11) in patients with unresectable adenocarcinoma of the esophagus and gastric cardia who have failed prior chemotherapy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus