Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00004922

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma of Unknown Primary Neuroendocrine Carcinoma Neuroendocrine Carcinoma of the Skin	Drug: irinotecan hydrochloride	Phase 2

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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 1999

Actual Primary Completion Date :

Jun 1, 2002

Actual Study Completion Date :

Jun 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically proven metastatic or unresectable high grade neuroendocrine tumor including:
Small cell carcinoma
Large cell neuroendocrine carcinoma
Other high grade neuroendocrine carcinomas without specification to cell size
No lung only involvement without any other primary site
No primary small cell lung cancer with or without metastases
Bidimensionally measurable disease with at least one lesion measuring at least 1 cm by 1 cm
High grade tumor indicated by at least one of the following:
Growth pattern suggestive of neuroendocrine differentiation
Mitotic rate greater than 15 mitoses per 10 hpf
Presence of abundant necrosis
Immunohistochemical evidence of neuroendocrine differentiation by positive staining for chromogranin, synaptophysin, or neuron specific enolase if no classic microscopic appearance of small cell carcinoma
No low grade neuroendocrine tumors (e.g., carcinoid tumors, pancreatic endocrine tumors) and atypical tumors