Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
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