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A Phase II Trial of CPT-11 in Patients With Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Incorporating Pretreatment and Posttreatment Biopsies for Evaluation of Tumor Thymidylate Synthase, MIB-1, Topoisomerase I, and p53

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

A Phase II Trial of CPT-11 in Patients With Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Incorporating Pretreatment and Posttreatment Biopsies for Evaluation of Tumor Thymidylate Synthase, MIB-1, Topoisomerase I, and p53

OBJECTIVES: I. Evaluate the response rate, survival, and toxicity of previously untreated
patients with locally advanced or metastatic gastric cancer who are treated with irinotecan

OUTLINE: This is a nonrandomized study. Patients receive irinotecan (CPT-11) by IV over 90
minutes every 3 weeks. Dosage modifications are made based on toxicity. Retreatment may be
delayed another 3 weeks (for a total of 6 weeks) to allow for recovery from toxic effects.
Patient is taken off study if they do not recover from toxic effects, unless cause is
documented to be unrelated to CPT-11. Patients with stable disease or partial response
continue on treatment until disease progression or intolerable toxicity. Patients with
complete response continue on treatment for another 2 courses and then are observed.
Patients are followed every 3 months for 3 years or until disease progression.

PROJECTED ACCRUAL: A minimum of 21 and a maximum of 66 patients will be accrued into this

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the stomach
or gastroesophageal junction beyond hope of surgical cure and not considered a candidate
for potentially curative chemotherapy/radiation therapy Measurable or evaluable disease
Tumor must be accessible for biopsy No known central nervous system metastases or
carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 150,000/mm3 Hemoglobin at least 9.0 mg/dL (transfusion allowed) Hepatic:
Bilirubin no greater than upper limit of normal (ULN), regardless of liver involvement
secondary to tumor AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5
times ULN Cardiovascular: No unstable angina No uncontrolled high blood pressure No active
congestive heart failure No myocardial infarction in the last 6 months No serious
uncontrolled cardiac arrhythmia No New York Heart Association Class III or IV heart
disease Pulmonary: No interstitial pneumonia or extensive and symptomatic interstitial
fibrosis of the lung No pleural effusion or ascites, which cause respiratory compromise
(at least Grade 2 dyspnea) Other: No active or uncontrolled infection No prior malignancy,
except for adequately treated basal cell or squamous cell skin cancer, adequately treated
noninvasive carcinomas, or other cancer from which the patient has been disease free for
at least 5 years Not pregnant or nursing Adequate contraception required of all fertile

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for gastric or gastroesophageal junction cancer No prior irinotecan (CPT-11)
or other camptothecin Endocrine therapy: Not specified Radiotherapy: No prior abdominal or
pelvic radiotherapy No prior radiotherapy to greater than 25% of bone marrow No prior
radiotherapy to measurable or evaluable indicator lesions At least 4 weeks since major
radiotherapy (chest radiotherapy) Surgery: At least 3 weeks since major surgery and
recovered At least 2 weeks since minor surgery and recovered Other: No other concurrent
investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard M. Goldberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage IV gastric cancer
  • stage IV esophageal cancer
  • adenocarcinoma of the esophagus
  • intestinal adenocarcinoma of the stomach
  • diffuse adenocarcinoma of the stomach
  • mixed adenocarcinoma of the stomach
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CentraCare Clinic Saint Cloud, Minnesota  56303
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Altru Health Systems Grand Forks, North Dakota  58201
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Mayo Clinic Jacksonville Jacksonville, Florida  32224
Medcenter One Health System Bismarck, North Dakota  58501