Status:
TERMINATED
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan. Secondary * Determine the safety and tole...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00100828
Start Date
November 1 2004
End Date
November 1 2008
Last Update
December 6 2018
Active Locations (2)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
2
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942