Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors
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 neuroendocrine tumors.
|Carcinoma of Unknown Primary Neuroendocrine Carcinoma Neuroendocrine Carcinoma of the Skin||Drug: irinotecan hydrochloride||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors|
|Study Start Date:||June 1999|
|Study Completion Date:||June 2002|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
- Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors.
- Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population.
OUTLINE: Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 10-31 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004922
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Sunil Sharma, MD||Memorial Sloan Kettering Cancer Center|