Irinotecan in Treating Patients With Esophageal or Stomach Cancer

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

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.

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.

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