Irinotecan in Treating Patients With Esophageal or Stomach Cancer

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00003748

Collaborator

Pharmacia and Upjohn (Industry)

Enrollment

Locations

Arm

Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer	Drug: irinotecan hydrochloride	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 1998

Actual Primary Completion Date :

Jun 1, 2000

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

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

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

Other Names:

CPT-11

Outcome Measures

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 [2 years]

Secondary Outcome Measures

Evaluate the toxicities of irinotecan hydrochloride (CPT-11) in the patient population [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Blood and Cancer Center	Bakersfield	California	United States	93309
2	St Jude Heritage Health Foundation	Fullerton	California	United States	92835
3	Daniel Freeman Memorial Hospital	Inglewood	California	United States	90301
4	UCLA - Antelope Valley Cancer Center	Lancaster	California	United States	93534
5	Pacific Shores Medical Group	Long Beach	California	United States	90813
6	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
7	Office of Eddie Hu, M.D.	Monterey Park	California	United States	91754
8	Community Hospital of the Monterey Peninsula	Monterey	California	United States	93940
9	Office of Jerome L. Rubin	Monterey	California	United States	93940
10	Ventura County Hematology-Oncology Medical Group, Inc.	Oxnard	California	United States	93030
11	Wilshire Oncology Medical Center	Pomona	California	United States	91767
12	Salinas Valley Memorial Hospital	Salinas	California	United States	93901
13	Cancer Center of Santa Barbara	Santa Barbara	California	United States	93105
14	Sansum Medical Clinic	Santa Barbara	California	United States	93105
15	James L. Poth, M.D., Michael Alexander, M.D., Inc.	Santa Cruz	California	United States	95065
16	Marian Medical Center	Santa Maria	California	United States	93454
17	Office of Marilou Terpenning	Santa Monica	California	United States	90404
18	Office of Robert C. Klein	Santa Monica	California	United States	90404
19	Dominican and Watsonville Community Hospital	Soquel	California	United States	95073
20	Los Robles Regional Medical Center	Thousand Oaks	California	United States	91360
21	Cancer Care Associates Medical Group	Torrance	California	United States	90505
22	UCLA Cancer Center - Santa Clarita	Valencia	California	United States	91355
23	Oncology Medical Center of North County	Vista	California	United States	92083
24	Valley Hematology and Oncology	West Hills	California	United States	91307
25	Cancer Care Consultants	Las Vegas	Nevada	United States	89119