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Irinotecan in Treating Patients With Advanced Cancer of the Stomach

This study has been completed.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003137
  Purpose

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 advanced cancer of the stomach.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: irinotecan hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders    Stomach Cancer   

Drug Information available for:   Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 1997

Detailed Description:

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 (CPT-11).

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 study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 patients

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003137

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program    
      Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic Jacksonville    
      Jacksonville, Florida, United States, 32224
United States, Illinois
CCOP - Carle Cancer Center    
      Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association    
      Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project    
      Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association    
      Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology    
      Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita    
      Wichita, Kansas, United States, 67214-3882
United States, Minnesota
CCOP - Duluth    
      Duluth, Minnesota, United States, 55805
CentraCare Clinic    
      Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center    
      Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium    
      Omaha, Nebraska, United States, 68131
United States, North Dakota
Altru Health Systems    
      Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital    
      Fargo, North Dakota, United States, 58122
Medcenter One Health System    
      Bismarck, North Dakota, United States, 58501
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center    
      Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
CCOP - Sioux Community Cancer Consortium    
      Sioux Falls, South Dakota, United States, 57104
Rapid City Regional Hospital    
      Rapid City, South Dakota, United States, 57709
Canada, Saskatchewan
Allan Blair Cancer Centre    
      Regina, Saskatchewan, Canada, S4T 7T1

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Richard M. Goldberg, MD     Mayo Clinic    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Erlichman C, Goldberg RM, Mahoney MR, et al.: A phase II trial of CPT-11 in patients (pts) with advanced gastric or gastroesophageal (GE) junction adenocarcinoma (ADCA): a clinical and pharmacodynamic evaluation. A North Central Cancer Treatment Group (NCCTG) study. [Abstract] J Clin Oncol 23 (Suppl 16): A-4026, 314s, 2005.
 

Study ID Numbers:   CDR0000065905, NCCTG-964152
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003137
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Irinotecan
Stomach cancer
Camptothecin
Carcinoma
Digestive System Diseases
Stomach Diseases
Stomach Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Adenocarcinoma
Esophageal neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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