Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

NCT ID: NCT00004922

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30
• Study Completion Date: 2002-06-30

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.

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Sunil Sharma, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000067605

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G00-1683

Identifier Type: -

Identifier Source: secondary_id

99-041

Identifier Type: -

Identifier Source: org_study_id