Irinotecan 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