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
(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.
Interventional
Primary Purpose: Treatment
Richard M. Goldberg, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000065905
NCT00003137
December 1997
Name | Location |
---|---|
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 |