Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00100828
First received: January 6, 2005
Last updated: October 1, 2010
Last verified: October 2010

January 6, 2005
October 1, 2010
November 2004
November 2008   (final data collection date for primary outcome measure)
Response rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00100828 on ClinicalTrials.gov Archive Site
Safety and tolerability [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
Drug: irinotecan hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Not Provided
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100828
JHOC-J0459, CDR0000409567, P50CA096784, P30CA006973, JHOC-J0459, JHOC-04080402
Not Provided
Arlene A. Forastiere, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Arlene A. Forastiere, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP