Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
- Registration Number
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Irinotecan irinotecan hydrochloride -
- Primary Outcome Measures
Name Time Method Response Rate Every 2 cycles To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States