NCT00004922

Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 neuroendocrine tumors.

Detailed description

OBJECTIVES: * 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.

Conditions

• Carcinoma of Unknown Primary
• Neuroendocrine Carcinoma
• Neuroendocrine Carcinoma of the Skin

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride

Timeline

• Start date: 1999-06-01
• Primary completion: 2002-06-01
• Completion: 2002-06-01
• First posted: 2003-10-01
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States