Irinotecan in Treating Patients With Esophageal or Stomach Cancer
Esophageal Cancer, Gastric Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- Comprehensive Blood and Cancer Center
- St Jude Heritage Health Foundation
- Daniel Freeman Memorial Hospital
- UCLA - Antelope Valley Cancer Center
- Pacific Shores Medical Group
- Jonsson Comprehensive Cancer Center, UCLA
- Office of Eddie Hu, M.D.
- Community Hospital of the Monterey Peninsula
- Office of Jerome L. Rubin
- Ventura County Hematology-Oncology Medical Group, Inc.
- Wilshire Oncology Medical Center
- Salinas Valley Memorial Hospital
- Cancer Center of Santa Barbara
- Sansum Medical Clinic
- James L. Poth, M.D., Michael Alexander, M.D., Inc.
- Marian Medical Center
- Office of Marilou Terpenning
- Office of Robert C. Klein
- Dominican and Watsonville Community Hospital
- Los Robles Regional Medical Center
- Cancer Care Associates Medical Group
- UCLA Cancer Center - Santa Clarita
- Oncology Medical Center of North County
- Valley Hematology and Oncology
- Cancer Care Consultants
Arms of the Study
Arm 1
Experimental
irinotecan hydrochloride
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.