Closed due to early stopping rule

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.

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.

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