Spots Global Cancer Trial Database for Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

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Trial Identification

Brief Title: Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

Official Title: Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer

Study ID: NCT00100828

Conditions

Head and Neck Cancer

Interventions

irinotecan hydrochloride

Study Description

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.