NCT00004922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

October 1, 2003

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

March 7, 2000

Last Update Submit

June 18, 2013

Conditions

Carcinoma of Unknown PrimaryNeuroendocrine CarcinomaNeuroendocrine Carcinoma of the Skin

Keywords

newly diagnosed carcinoma of unknown primaryrecurrent carcinoma of unknown primarystage III neuroendocrine carcinoma of the skinrecurrent neuroendocrine carcinoma of the skinneuroendocrine carcinoma

Interventions

irinotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Neoplasms, Unknown PrimaryCarcinoma, NeuroendocrineCarcinoma, Merkel Cell

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePolyomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Sunil Sharma, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

October 1, 2003

Study Start

June 1, 1999

Primary Completion

June 1, 2002

Study Completion

June 1, 2002

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)