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 : Completed
First Posted : January 7, 2005
Last Update Posted : October 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: irinotecan hydrochloride||Phase 2|
- Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Drug: irinotecan hydrochloride
- Response rate [ Time Frame: Every 2 cycles ]To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100828
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|Study Chair:||Arlene A. Forastiere, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|