Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
|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|
|Experimental: Irinotecan||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
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|