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

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

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Trial Information

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

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.

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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Joel R. Hecht, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

January 2005

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • 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
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Cancer Center of Santa Barbara Santa Barbara, California  93105
Salinas Valley Memorial Hospital Salinas, California  93901
Community Hospital of the Monterey Peninsula Monterey, California  93940
Wilshire Oncology Medical Center Pomona, California  91767
Comprehensive Blood and Cancer Center Bakersfield, California  93309
St Jude Heritage Health Foundation Fullerton, California  92835
Daniel Freeman Memorial Hospital Inglewood, California  90301
UCLA - Antelope Valley Cancer Center Lancaster, California  93534
Pacific Shores Medical Group Long Beach, California  90813
Office of Jerome L. Rubin Monterey, California  93940
Office of Eddie Hu, M.D. Monterey Park, California  91754
Ventura County Hematology-Oncology Medical Group, Inc. Oxnard, California  93030
Sansum Medical Clinic Santa Barbara, California  93105
James L. Poth, M.D., Michael Alexander, M.D., Inc. Santa Cruz, California  95065
Marian Medical Center Santa Maria, California  93454
Office of Robert C. Klein Santa Monica, California  90404
Office of Marilou Terpenning Santa Monica, California  90404
Dominican and Watsonville Community Hospital Soquel, California  95073
Los Robles Regional Medical Center Thousand Oaks, California  91360
Cancer Care Associates Medical Group Torrance, California  90505
UCLA Cancer Center - Santa Clarita Valencia, California  91355
Oncology Medical Center of North County Vista, California  92083
Valley Hematology and Oncology West Hills, California  91307
Cancer Care Consultants Las Vegas, Nevada  89119