Irinotecan in Treating Patients With Esophageal or Stomach Cancer
- Conditions
- Esophageal CancerGastric Cancer
- Interventions
- Registration Number
- NCT00003748
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description irinotecan hydrochloride 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population 2 years
Trial Locations
- Locations (25)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Cancer Care Associates Medical Group
🇺🇸Torrance, California, United States
UCLA Cancer Center - Santa Clarita
🇺🇸Valencia, California, United States
St Jude Heritage Health Foundation
🇺🇸Fullerton, California, United States
Office of Jerome L. Rubin
🇺🇸Monterey, California, United States
Community Hospital of the Monterey Peninsula
🇺🇸Monterey, California, United States
Sansum Medical Clinic
🇺🇸Santa Barbara, California, United States
UCLA - Antelope Valley Cancer Center
🇺🇸Lancaster, California, United States
Dominican and Watsonville Community Hospital
🇺🇸Soquel, California, United States
Office of Robert C. Klein
🇺🇸Santa Monica, California, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Oncology Medical Center of North County
🇺🇸Vista, California, United States
James L. Poth, M.D., Michael Alexander, M.D., Inc.
🇺🇸Santa Cruz, California, United States
Cancer Center of Santa Barbara
🇺🇸Santa Barbara, California, United States
Marian Medical Center
🇺🇸Santa Maria, California, United States
Valley Hematology and Oncology
🇺🇸West Hills, California, United States
Daniel Freeman Memorial Hospital
🇺🇸Inglewood, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Ventura County Hematology-Oncology Medical Group, Inc.
🇺🇸Oxnard, California, United States
Office of Eddie Hu, M.D.
🇺🇸Monterey Park, California, United States
Wilshire Oncology Medical Center
🇺🇸Pomona, California, United States
Salinas Valley Memorial Hospital
🇺🇸Salinas, California, United States
Los Robles Regional Medical Center
🇺🇸Thousand Oaks, California, United States
Office of Marilou Terpenning
🇺🇸Santa Monica, California, United States
Cancer Care Consultants
🇺🇸Las Vegas, Nevada, United States