A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract
Both irinotecan and carboplatin are drugs commonly used to treat cancer.
Before treatment starts, patients will have blood tests (around 4 teaspoons) and urine
tests. Patients will have a chest X-ray, an electrocardiogram (ECG-a test to measure the
electrical activity of the heart), and a computed tomography (CT) scan. Women who are able
to have children must have a negative blood pregnancy test.
During the study, patients will receive irinotecan and cisplatin by vein over 4 hours, once
a week for 2 weeks. This will be followed by 7 days in which no treatment will be given.
This 3 week period is called a cycle. Cycles will be repeated unless the tumor continues to
During treatment, patients will have follow-up visits every 3 weeks to check for any side
effects and the status of the disease. The follow-up visits may be with either your local
doctor or with the study doctor. However, visits with the study doctor should be scheduled
at least every 9 weeks. If the disease gets worse or you experience any intolerable side
effects, you will be taken off the study.
This is an investigational study. Both irinotecan and cisplatin are FDA approved and
commercially available. Around 36 patients will participate in the study. All patients will
be enrolled at M.D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Participant Response Rate of Irinotecan and Cisplatin
Clinical activity defined by number of participants with Complete Response (CR) and Partial Response (PR) divided by total number of particpants using Response Evaluation Criteria in Solid Tumors (RECIST) where changes in tumor measurements confirmed by repeat assessments no less than 4 weeks after criteria for CR and PR responses first met.
Every 3 weeks
James C. Yao, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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