Clinical trial NCT00100828: Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Official title: Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: thyroid gland medullary carcinoma
recurrent thyroid cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-01-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer.

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 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 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

Primary outcomes:
measure: Response Rate
timeFrame: Every 2 cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Arlene A. Forastiere, MD
role: STUDY_CHAIR
References: