Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004922
First received: March 7, 2000
Last updated: July 23, 2008
Last verified: September 2002
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Carcinoma of Unknown Primary Neuroendocrine Carcinoma Neuroendocrine Carcinoma of the Skin |
Drug: irinotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | June 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004922
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Study Chair: | Sunil Sharma, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004922 History of Changes |
| Other Study ID Numbers: | CDR0000067605, MSKCC-99041, NCI-G00-1683 |
| Study First Received: | March 7, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Neuroendocrine Tumors Neoplasms, Unknown Primary Skin Neoplasms Carcinoma, Basal Cell Carcinoma, Basosquamous Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma |
Neoplasms, Nerve Tissue Neoplasm Metastasis Neoplastic Processes Pathologic Processes Neoplasms by Site Skin Diseases Neoplasms, Basal Cell Neoplasms, Squamous Cell Irinotecan Camptothecin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013