Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract
1. Assess the clinical activity defined by response rate of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.
1. To assess the safety profile of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Irinotecan and Cisplatin for Metastatic or Unresectable High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract|
- Participant Response Rate of Irinotecan and Cisplatin [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||March 2003|
|Study Completion Date:||July 2009|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Experimental: Irinotecan plus Cisplatin
Irinotecan 65 mg/m2 and Cisplatin 25 mg/m2 intravenous (IV) days 1, 8 of a 21-day cycle
Cisplatin 25 mg/m2 IV days 1, 8 of a 21-day cycle
Other Names:Drug: Irinotecan
Irinotecan 65 mg/m2 IV days 1, 8 of a 21-day cycle
Other Name: CPT-11
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 grow.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353015
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James C. Yao, MD||M.D. Anderson Cancer Center|