Irinotecan in Treating Patients With Esophageal or Stomach Cancer

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: Gastric Cancer; Esophageal Cancer
• Intervention / Treatment: Drug: irinotecan hydrochloride

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

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Pharmacia and Upjohn
• Investigators: Principal Investigator: Joel R. Hecht, MD, Jonsson Comprehensive Cancer Center

Study record dates

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: stage IV gastric cancer; recurrent gastric cancer; stage III gastric cancer; stage II esophageal cancer; stage III esophageal cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus; recurrent esophageal cancer; stage IV esophageal cancer; stage I gastric cancer; stage II gastric cancer; stage I esophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Neoplasms; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: CDR0000066868; UCLA-HSPC-9703008; P-UPHJOHN-6475-96014; NCI-G99-1497