Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

Neuroendocrine Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004922
• Other study ID #: 99-041
• Secondary ID: CDR0000067605NCI
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: June 18, 2013
• Start date: June 1999
• Est. completion date: June 2002

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 75,000/mm^3

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• SGOT no greater than 5 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No myocardial infarction within the past 6 months

• No uncontrolled congestive heart failure requiring therapy

Other:

• No active or uncontrolled infection

• HIV negative

• No psychiatric or other disorder that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No more than 2 prior chemotherapy regimens

• No prior camptothecins

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma
• Carcinoma of Unknown Primary
• Carcinoma, Merkel Cell
• Carcinoma, Neuroendocrine
• Neoplasms, Unknown Primary
• Neuroendocrine Carcinoma
• Neuroendocrine Carcinoma of the Skin
• Neuroendocrine Tumors
• Skin Neoplasms

Intervention

Drug:
• irinotecan hydrochloride

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,