Irinotecan in Treating Patients With Esophageal or Stomach Cancer
Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia
4 other identifiers
interventional
40
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 1998
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2000
CompletedFirst Posted
Study publicly available on registry
July 22, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedAugust 3, 2020
July 1, 2012
1.8 years
November 1, 1999
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population
2 years
Study Arms (1)
irinotecan hydrochloride
EXPERIMENTALOne 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
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- Pharmacia and Upjohncollaborator
Study Sites (25)
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
St Jude Heritage Health Foundation
Fullerton, California, 92835, United States
Daniel Freeman Memorial Hospital
Inglewood, California, 90301, United States
UCLA - Antelope Valley Cancer Center
Lancaster, California, 93534, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Community Hospital of the Monterey Peninsula
Monterey, California, 93940, United States
Office of Jerome L. Rubin
Monterey, California, 93940, United States
Office of Eddie Hu, M.D.
Monterey Park, California, 91754, United States
Ventura County Hematology-Oncology Medical Group, Inc.
Oxnard, California, 93030, United States
Wilshire Oncology Medical Center
Pomona, California, 91767, United States
Salinas Valley Memorial Hospital
Salinas, California, 93901, United States
Cancer Center of Santa Barbara
Santa Barbara, California, 93105, United States
Sansum Medical Clinic
Santa Barbara, California, 93105, United States
James L. Poth, M.D., Michael Alexander, M.D., Inc.
Santa Cruz, California, 95065, United States
Marian Medical Center
Santa Maria, California, 93454, United States
Office of Marilou Terpenning
Santa Monica, California, 90404, United States
Office of Robert C. Klein
Santa Monica, California, 90404, United States
Dominican and Watsonville Community Hospital
Soquel, California, 95073, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
Cancer Care Associates Medical Group
Torrance, California, 90505, United States
UCLA Cancer Center - Santa Clarita
Valencia, California, 91355, United States
Oncology Medical Center of North County
Vista, California, 92083, United States
Valley Hematology and Oncology
West Hills, California, 91307, United States
Cancer Care Consultants
Las Vegas, Nevada, 89119, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel R. Hecht, MD
Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
July 22, 2004
Study Start
August 1, 1998
Primary Completion
June 1, 2000
Study Completion
January 1, 2005
Last Updated
August 3, 2020
Record last verified: 2012-07