Irinotecan in Treating Patients With Esophageal or Stomach Cancer
NCT ID: NCT00003748
Last Updated: 2020-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
1998-08-31
2005-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Pharmacia and Upjohn
INDUSTRY
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Joel R. Hecht, MD
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
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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
Countries
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Other Identifiers
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UCLA-HSPC-9703008
Identifier Type: -
Identifier Source: secondary_id
P-UPHJOHN-6475-96014
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1497
Identifier Type: -
Identifier Source: secondary_id
CDR0000066868
Identifier Type: -
Identifier Source: org_study_id
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