Irinotecan in Treating Patients With Esophageal or Stomach Cancer

July 30, 2020 updated by: Jonsson Comprehensive Cancer Center

Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • CPT-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Pharmacia and Upjohn

Investigators

  • Principal Investigator: Joel R. Hecht, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (Actual)

June 1, 2000

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 21, 2004

First Posted (Estimate)

July 22, 2004

Study Record Updates

Last Update Posted (Actual)

August 3, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066868
  • UCLA-HSPC-9703008
  • P-UPHJOHN-6475-96014
  • NCI-G99-1497

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on irinotecan hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe