NCT00100828

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

2 active sites

Status
terminated

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

November 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
10.1 years until next milestone

Results Posted

Study results publicly available

December 6, 2018

Completed
Last Updated

December 6, 2018

Status Verified

November 1, 2018

Enrollment Period

4 years

First QC Date

January 6, 2005

Results QC Date

March 6, 2017

Last Update Submit

November 12, 2018

Conditions

Head and Neck Cancer

Keywords

thyroid gland medullary carcinomarecurrent thyroid cancer

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    To determine the response rate of this regimen of irinotecan in patients with metastatic MTC

    Every 2 cycles

Study Arms (1)

Irinotecan

EXPERIMENTAL
Drug: irinotecan hydrochloride

Interventions

irinotecan hydrochlorideDRUG
Irinotecan

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed medullary thyroid cancer
  • Metastatic or inoperable locoregional disease
  • Measurable disease by CT scan
  • years and over
  • ECOG PS 0-1
  • Adequate lab functions including:
  • Granulocyte count \> 1,000/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Bilirubin \< 1.5 mg/dL
  • ALT and AST \< 2.5 times upper limit of normal
  • No unstable or uncompensated hepatic disease
  • Creatinine clearance \> 60 mL/min
  • No unstable or uncompensated renal disease
  • Negative pregnancy test
  • More than 3 months since prior biologic therapy
  • +5 more criteria

You may not qualify if:

  • Patients with elevated calcitonin levels as the only measurement of disease are not eligible
  • Unstable or uncompensated cardiovascular disease
  • Unstable or uncompensated respiratory disease
  • Pregnant or nursing
  • Diarrhea ≥ grade 2 (antidiarrheals allowed)
  • Other severe or uncontrolled systemic disease
  • Other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer
  • Illness that would preclude study participation
  • Significant clinical disorder or laboratory finding that would preclude study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, MedullaryThyroid Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Results Point of Contact

Title
Arlene Forastiere
Organization
SKCCC at Johns Hopkins
af@jhmi.edu
410-955-9818

Study Officials

  • Arlene A. Forastiere, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2005

First Posted

January 7, 2005

Study Start

November 1, 2004

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 6, 2018

Results First Posted

December 6, 2018

Record last verified: 2018-11

Locations

US(2)