Irinotecan in Treating Patients With Esophageal or Stomach Cancer

Completed · Phase 2

Conditions studied: Esophageal Cancer, Gastric Cancer

In brief

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.

Key facts

Study ID

NCT00003748

Run by

Jonsson Comprehensive Cancer Center

People needed

40

Starts

1998-08-01

Expected to finish

2005-01-01

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• St Jude Heritage Health Foundation — Fullerton, California, United States
• Daniel Freeman Memorial Hospital — Inglewood, California, United States
• UCLA - Antelope Valley Cancer Center — Lancaster, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States
• Community Hospital of the Monterey Peninsula — Monterey, California, United States
• Office of Jerome L. Rubin — Monterey, California, United States
• Office of Eddie Hu, M.D. — Monterey Park, California, United States
• Ventura County Hematology-Oncology Medical Group, Inc. — Oxnard, California, United States
• Wilshire Oncology Medical Center — Pomona, California, United States
• Salinas Valley Memorial Hospital — Salinas, California, United States
• Cancer Center of Santa Barbara — Santa Barbara, California, United States
• Sansum Medical Clinic — Santa Barbara, California, United States
• James L. Poth, M.D., Michael Alexander, M.D., Inc. — Santa Cruz, California, United States
• Marian Medical Center — Santa Maria, California, United States
• Office of Marilou Terpenning — Santa Monica, California, United States
• Office of Robert C. Klein — Santa Monica, California, United States
• Dominican and Watsonville Community Hospital — Soquel, California, United States
• Los Robles Regional Medical Center — Thousand Oaks, California, United States
• Cancer Care Associates Medical Group — Torrance, California, United States
• UCLA Cancer Center - Santa Clarita — Valencia, California, United States
• Oncology Medical Center of North County — Vista, California, United States
• Valley Hematology and Oncology — West Hills, California, United States
• Cancer Care Consultants — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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