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.

DISEASE CHARACTERISTICS:

• Histologically confirmed medullary thyroid cancer

  • Metastatic or inoperable locoregional disease

• Measurable disease by CT scan

  • Patients with elevated calcitonin levels as the only measurement of disease are not eligible

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count > 1,000/mm^3
• Platelet count > 100,000/mm^3

Hepatic

• Bilirubin < 1.5 mg/dL
• ALT and AST < 2.5 times upper limit of normal
• No unstable or uncompensated hepatic disease

Renal

• Creatinine clearance > 60 mL/min
• No unstable or uncompensated renal disease

Cardiovascular

• No unstable or uncompensated cardiovascular disease

Pulmonary

• No unstable or uncompensated respiratory disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• No diarrhea ≥ grade 2 (antidiarrheals allowed)
• No other severe or uncontrolled systemic disease
• No other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer
• No other illness that would preclude study participation
• No other significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 3 months since prior biologic therapy

Chemotherapy

• More than 3 months since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to > 25% of bone marrow
• More than 3 months since prior radiotherapy

Surgery

• Recovered from prior oncologic or other major surgery

Other

• More than 30 days since prior non-approved or investigational drugs