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
  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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100828

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
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
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 April 16, 2014