search
Back to results

Irinotecan in Treating Patients With Esophageal or Stomach Cancer

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Blood and Cancer Center
  • St Jude Heritage Health Foundation
  • Daniel Freeman Memorial Hospital
  • UCLA - Antelope Valley Cancer Center
  • Pacific Shores Medical Group
  • Jonsson Comprehensive Cancer Center, UCLA
  • Office of Eddie Hu, M.D.
  • Community Hospital of the Monterey Peninsula
  • Office of Jerome L. Rubin
  • Ventura County Hematology-Oncology Medical Group, Inc.
  • Wilshire Oncology Medical Center
  • Salinas Valley Memorial Hospital
  • Cancer Center of Santa Barbara
  • Sansum Medical Clinic
  • James L. Poth, M.D., Michael Alexander, M.D., Inc.
  • Marian Medical Center
  • Office of Marilou Terpenning
  • Office of Robert C. Klein
  • Dominican and Watsonville Community Hospital
  • Los Robles Regional Medical Center
  • Cancer Care Associates Medical Group
  • UCLA Cancer Center - Santa Clarita
  • Oncology Medical Center of North County
  • Valley Hematology and Oncology
  • Cancer Care Consultants

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

irinotecan hydrochloride

Arm Description

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.

Outcomes

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

Secondary Outcome Measures

Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population

Full Information

First Posted
November 1, 1999
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Pharmacia and Upjohn
search

1. Study Identification

Unique Protocol Identification Number
NCT00003748
Brief Title
Irinotecan in Treating Patients With Esophageal or Stomach Cancer
Official Title
Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
June 2000 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Pharmacia and Upjohn

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
irinotecan hydrochloride
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
CPT-11
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel R. Hecht, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
St Jude Heritage Health Foundation
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Daniel Freeman Memorial Hospital
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
UCLA - Antelope Valley Cancer Center
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Office of Eddie Hu, M.D.
City
Monterey Park
State/Province
California
ZIP/Postal Code
91754
Country
United States
Facility Name
Community Hospital of the Monterey Peninsula
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Office of Jerome L. Rubin
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Ventura County Hematology-Oncology Medical Group, Inc.
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Wilshire Oncology Medical Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Salinas Valley Memorial Hospital
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Cancer Center of Santa Barbara
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Sansum Medical Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
James L. Poth, M.D., Michael Alexander, M.D., Inc.
City
Santa Cruz
State/Province
California
ZIP/Postal Code
95065
Country
United States
Facility Name
Marian Medical Center
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Office of Marilou Terpenning
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Office of Robert C. Klein
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Dominican and Watsonville Community Hospital
City
Soquel
State/Province
California
ZIP/Postal Code
95073
Country
United States
Facility Name
Los Robles Regional Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Cancer Care Associates Medical Group
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
UCLA Cancer Center - Santa Clarita
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Facility Name
Oncology Medical Center of North County
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Valley Hematology and Oncology
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Cancer Care Consultants
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Irinotecan in Treating Patients With Esophageal or Stomach Cancer

We'll reach out to this number within 24 hrs