Irinotecan in Treating Patients With Esophageal or Stomach Cancer

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); Pharmacia and Upjohn
• Treatments: Camptothecin; Irinotecan

Criteria

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