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Phase II Study of Irinotecan (CPT-11) in Adenocarcinoma of the Esophagus and Gastric Cardia (NCT00003748)

National Cancer Institute (NCI)
Pharmacia and Upjohn
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.
  • 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.
    • CPT-11
Ages eligible for Study
18 Years and older
Genders eligible for Study
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
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.

25 locations

United States (25)
  • Comprehensive Blood and Cancer Center
    Not specified
    Bakersfield, California, United States, 93309
  • St Jude Heritage Health Foundation
    Not specified
    Fullerton, California, United States, 92835
  • Daniel Freeman Memorial Hospital
    Not specified
    Inglewood, California, United States, 90301
  • UCLA - Antelope Valley Cancer Center
    Not specified
    Lancaster, California, United States, 93534
  • Pacific Shores Medical Group
    Not specified
    Long Beach, California, United States, 90813
  • Jonsson Comprehensive Cancer Center, UCLA
    Not specified
    Los Angeles, California, United States, 90095-1781
  • Office of Eddie Hu, M.D.
    Not specified
    Monterey Park, California, United States, 91754
  • Community Hospital of the Monterey Peninsula
    Not specified
    Monterey, California, United States, 93940
  • Office of Jerome L. Rubin
    Not specified
    Monterey, California, United States, 93940
  • Ventura County Hematology-Oncology Medical Group, Inc.
    Not specified
    Oxnard, California, United States, 93030
  • Wilshire Oncology Medical Center
    Not specified
    Pomona, California, United States, 91767
  • Salinas Valley Memorial Hospital
    Not specified
    Salinas, California, United States, 93901
  • Cancer Center of Santa Barbara
    Not specified
    Santa Barbara, California, United States, 93105
  • Sansum Medical Clinic
    Not specified
    Santa Barbara, California, United States, 93105
  • James L. Poth, M.D., Michael Alexander, M.D., Inc.
    Not specified
    Santa Cruz, California, United States, 95065
  • Marian Medical Center
    Not specified
    Santa Maria, California, United States, 93454
  • Office of Marilou Terpenning
    Not specified
    Santa Monica, California, United States, 90404
  • Office of Robert C. Klein
    Not specified
    Santa Monica, California, United States, 90404
  • Dominican and Watsonville Community Hospital
    Not specified
    Soquel, California, United States, 95073
  • Los Robles Regional Medical Center
    Not specified
    Thousand Oaks, California, United States, 91360
  • Cancer Care Associates Medical Group
    Not specified
    Torrance, California, United States, 90505
  • UCLA Cancer Center - Santa Clarita
    Not specified
    Valencia, California, United States, 91355
  • Oncology Medical Center of North County
    Not specified
    Vista, California, United States, 92083
  • Valley Hematology and Oncology
    Not specified
    West Hills, California, United States, 91307
  • Cancer Care Consultants
    Not specified
    Las Vegas, Nevada, United States, 89119
31 July, 1998
27 October, 2015
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