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Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00100828
Recruitment Status : Terminated (Closed due to early stopping rule)
First Posted : January 7, 2005
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE January 6, 2005
First Posted Date  ICMJE January 7, 2005
Results First Submitted Date  ICMJE March 6, 2017
Results First Posted Date  ICMJE December 6, 2018
Last Update Posted Date December 6, 2018
Study Start Date  ICMJE November 2004
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
Response Rate [ Time Frame: Every 2 cycles ]
To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Official Title  ICMJE Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
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.

Detailed Description

OBJECTIVES:

Primary

  • Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan.

Secondary

  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Response is assessed after completion of 4 courses. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients who have stable disease receive up to 12 total courses.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Drug: irinotecan hydrochloride
Study Arms  ICMJE Experimental: Irinotecan
Intervention: Drug: irinotecan hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 12, 2016)
6
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion

  • Histologically confirmed medullary thyroid cancer
  • Metastatic or inoperable locoregional disease
  • Measurable disease by CT scan
  • 18 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
  • More than 3 months since prior chemotherapy
  • No prior radiotherapy to > 25% of bone marrow
  • More than 3 months since prior radiotherapy
  • Recovered from prior oncologic or other major surgery
  • More than 30 days since prior non-approved or investigational drugs

Exclusion:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00100828
Other Study ID Numbers  ICMJE J0459
P50CA096784 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0459
JHOC-04080402
CDR0000409567 ( Other Identifier: other )
04-08-04-02 ( Other Identifier: JHM IRB )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Arlene A. Forastiere, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP