Irinotecan in Treating Patients With Esophageal or Stomach Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003748
• Other study ID #: CDR0000066868
• Secondary ID: UCLA-HSPC-970300
• Status: Completed
• Phase: Phase 2
• Start date: August 1998
• Est. completion date: January 2005

Study information

• Verified date: July 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2005
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	St Jude Heritage Health Foundation	Fullerton	California
United States	Daniel Freeman Memorial Hospital	Inglewood	California
United States	UCLA - Antelope Valley Cancer Center	Lancaster	California
United States	Cancer Care Consultants	Las Vegas	Nevada
United States	Pacific Shores Medical Group	Long Beach	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Community Hospital of the Monterey Peninsula	Monterey	California
United States	Office of Jerome L. Rubin	Monterey	California
United States	Office of Eddie Hu, M.D.	Monterey Park	California
United States	Ventura County Hematology-Oncology Medical Group, Inc.	Oxnard	California
United States	Wilshire Oncology Medical Center	Pomona	California
United States	Salinas Valley Memorial Hospital	Salinas	California
United States	Cancer Center of Santa Barbara	Santa Barbara	California
United States	Sansum Medical Clinic	Santa Barbara	California
United States	James L. Poth, M.D., Michael Alexander, M.D., Inc.	Santa Cruz	California
United States	Marian Medical Center	Santa Maria	California
United States	Office of Marilou Terpenning	Santa Monica	California
United States	Office of Robert C. Klein	Santa Monica	California
United States	Dominican and Watsonville Community Hospital	Soquel	California
United States	Los Robles Regional Medical Center	Thousand Oaks	California
United States	Cancer Care Associates Medical Group	Torrance	California
United States	UCLA Cancer Center - Santa Clarita	Valencia	California
United States	Oncology Medical Center of North County	Vista	California
United States	Valley Hematology and Oncology	West Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Pharmacia and Upjohn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population		2 years