Clinical trial NCT00003748: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Pharmacia and Upjohn
First posted: 2004-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population
timeFrame: 2 years
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Fullerton
country: United States
facility: St Jude Heritage Health Foundation
state: California
city: Inglewood
country: United States
facility: Daniel Freeman Memorial Hospital
state: California
city: Lancaster
country: United States
facility: UCLA - Antelope Valley Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Monterey Park
country: United States
facility: Office of Eddie Hu, M.D.
state: California
city: Monterey
country: United States
facility: Community Hospital of the Monterey Peninsula
state: California
city: Monterey
country: United States
facility: Office of Jerome L. Rubin
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Medical Group, Inc.
state: California
city: Pomona
country: United States
facility: Wilshire Oncology Medical Center
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Hospital
state: California
city: Santa Barbara
country: United States
facility: Cancer Center of Santa Barbara
state: California
city: Santa Barbara
country: United States
facility: Sansum Medical Clinic
state: California
city: Santa Cruz
country: United States
facility: James L. Poth, M.D., Michael Alexander, M.D., Inc.
state: California
city: Santa Maria
country: United States
facility: Marian Medical Center
state: California
city: Santa Monica
country: United States
facility: Office of Marilou Terpenning
state: California
city: Santa Monica
country: United States
facility: Office of Robert C. Klein
state: California
city: Soquel
country: United States
facility: Dominican and Watsonville Community Hospital
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Torrance
country: United States
facility: Cancer Care Associates Medical Group
state: California
city: Valencia
country: United States
facility: UCLA Cancer Center - Santa Clarita
state: California
city: Vista
country: United States
facility: Oncology Medical Center of North County
state: California
city: West Hills
country: United States
facility: Valley Hematology and Oncology
state: California
city: Las Vegas
country: United States
facility: Cancer Care Consultants
state: Nevada
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Joel R. Hecht, MD
role: PRINCIPAL_INVESTIGATOR
References: