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Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

Phase II Trial of Irinotecan for Treatment of Metastatic Medullary 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Arlene A. Forastiere, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

JHOC-J0459, CDR0000409567

NCT ID:

NCT00100828

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • thyroid gland medullary carcinoma
  • recurrent thyroid cancer
  • Thyroid Neoplasms
  • Head and Neck Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410