Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: irinotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer |
- Response rate [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 33 |
| Study Start Date: | November 2004 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Study Chair: | Arlene A. Forastiere, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Arlene A. Forastiere, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT00100828 History of Changes |
| Other Study ID Numbers: | JHOC-J0459, CDR0000409567, P50CA096784, P30CA006973, JHOC-J0459, JHOC-04080402 |
| Study First Received: | January 6, 2005 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
thyroid gland medullary carcinoma recurrent thyroid cancer |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Head and Neck Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases Thyroid Diseases Irinotecan Camptothecin Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013