Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Histologically confirmed medullary thyroid cancer Metastatic or inoperable locoregional disease Measurable disease by CT scan 18 years and over ECOG PS 0-1 Adequate lab functions including: Granulocyte count > 1,000/mm^3 Platelet count > 100,000/mm^3 Bilirubin < 1.5 mg/dL ALT and AST < 2.5 times upper limit of normal No unstable or uncompensated hepatic disease Creatinine clearance > 60 mL/min No unstable or uncompensated renal disease Negative pregnancy test More than 3 months since prior biologic therapy More than 3 months since prior chemotherapy No prior radiotherapy to > 25% of bone marrow More than 3 months since prior radiotherapy Recovered from prior oncologic or other major surgery More than 30 days since prior non-approved or investigational drugs Exclusion: Patients with elevated calcitonin levels as the only measurement of disease are not eligible Unstable or uncompensated cardiovascular disease Unstable or uncompensated respiratory disease Pregnant or nursing Diarrhea ≥ grade 2 (antidiarrheals allowed) Other severe or uncontrolled systemic disease Other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer Illness that would preclude study participation Significant clinical disorder or laboratory finding that would preclude study participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irinotecan<br> | Drug: irinotecan hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | To determine the response rate of this regimen of irinotecan in patients with metastatic MTC | Every 2 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid gland medullary carcinoma, recurrent thyroid cancer