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Spots Global Cancer Trial Database for Irinotecan in Treating Patients With Advanced Cancer of the Stomach

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Trial Identification

Brief Title: Irinotecan in Treating Patients With Advanced Cancer of the Stomach

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

Study ID: NCT00003137

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 advanced cancer of the stomach.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States

Mayo Clinic Jacksonville, Jacksonville, Florida, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

Siouxland Hematology-Oncology, Sioux City, Iowa, United States

CCOP - Wichita, Wichita, Kansas, United States

CCOP - Duluth, Duluth, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CentraCare Clinic, Saint Cloud, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Medcenter One Health System, Bismarck, North Dakota, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

Altru Health Systems, Grand Forks, North Dakota, United States

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States

Rapid City Regional Hospital, Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Contact Details

Name: Richard M. Goldberg, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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