Irinotecan in Treating Patients With Esophageal or Stomach Cancer

This study has been completed.
Sponsor:
Collaborators:
Pharmacia and Upjohn
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003748
First received: November 1, 1999
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: August 1998
Study Completion Date: January 2005
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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 Name: CPT-11

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003748

Locations
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
St Jude Heritage Health Foundation
Fullerton, California, United States, 92835
Daniel Freeman Memorial Hospital
Inglewood, California, United States, 90301
UCLA - Antelope Valley Cancer Center
Lancaster, California, United States, 93534
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Office of Jerome L. Rubin
Monterey, California, United States, 93940
Community Hospital of the Monterey Peninsula
Monterey, California, United States, 93940
Office of Eddie Hu, M.D.
Monterey Park, California, United States, 91754
Ventura County Hematology-Oncology Medical Group, Inc.
Oxnard, California, United States, 93030
Wilshire Oncology Medical Center
Pomona, California, United States, 91767
Salinas Valley Memorial Hospital
Salinas, California, United States, 93901
Cancer Center of Santa Barbara
Santa Barbara, California, United States, 93105
Sansum Medical Clinic
Santa Barbara, California, United States, 93105
James L. Poth, M.D., Michael Alexander, M.D., Inc.
Santa Cruz, California, United States, 95065
Marian Medical Center
Santa Maria, California, United States, 93454
Office of Robert C. Klein
Santa Monica, California, United States, 90404
Office of Marilou Terpenning
Santa Monica, California, United States, 90404
Dominican and Watsonville Community Hospital
Soquel, California, United States, 95073
Los Robles Regional Medical Center
Thousand Oaks, California, United States, 91360
Cancer Care Associates Medical Group
Torrance, California, United States, 90505
UCLA Cancer Center - Santa Clarita
Valencia, California, United States, 91355
Oncology Medical Center of North County
Vista, California, United States, 92083
Valley Hematology and Oncology
West Hills, California, United States, 91307
United States, Nevada
Cancer Care Consultants
Las Vegas, Nevada, United States, 89119
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Pharmacia and Upjohn
Investigators
Principal Investigator: Joel R. Hecht, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00003748     History of Changes
Other Study ID Numbers: CDR0000066868, P30CA016042, UCLA-HSPC-9703008, P-UPHJOHN-6475-96014, NCI-G99-1497
Study First Received: November 1, 1999
Last Updated: July 27, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014