search
Back to results

Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

Primary Purpose

Carcinoma of Unknown Primary, Neuroendocrine Carcinoma, Neuroendocrine Carcinoma of the Skin

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary, stage III neuroendocrine carcinoma of the skin, recurrent neuroendocrine carcinoma of the skin, neuroendocrine carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
June 18, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00004922
Brief Title
Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors
Official Title
A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of Unknown Primary, Neuroendocrine Carcinoma, Neuroendocrine Carcinoma of the Skin
Keywords
newly diagnosed carcinoma of unknown primary, recurrent carcinoma of unknown primary, stage III neuroendocrine carcinoma of the skin, recurrent neuroendocrine carcinoma of the skin, neuroendocrine carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Sharma, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

We'll reach out to this number within 24 hrs