Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Irinotecan

Criteria

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