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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Intervention Drug: irinotecan hydrochloride
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Irinotecan
Hide Arm/Group Description irinotecan hydrochloride
Period Title: Overall Study
Started 6
Completed [1] 0
Not Completed 6
Reason Not Completed
Physician Decision             6
[1]
Trial closed due to early stopping rule and low enrollment.
Arm/Group Title Irinotecan
Hide Arm/Group Description irinotecan hydrochloride
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  66.7%
>=65 years
2
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
71  (10.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Response Rate
Hide Description To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
Time Frame Every 2 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Study was closed to enrollment due to low accrual. Data was not collected for this outcome measure.
Arm/Group Title Irinotecan
Hide Arm/Group Description:
irinotecan hydrochloride
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Irinotecan
Hide Arm/Group Description irinotecan hydrochloride
All-Cause Mortality
Irinotecan
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Irinotecan
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Irinotecan
Affected / at Risk (%)
Total   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arlene Forastiere
Organization: SKCCC at Johns Hopkins
Phone: 410-955-9818
EMail: af@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00100828    
Other Study ID Numbers: 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 )
First Submitted: January 6, 2005
First Posted: January 7, 2005
Results First Submitted: March 6, 2017
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018