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Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00100828
Recruitment Status : Completed
First Posted : January 7, 2005
Last Update Posted : October 14, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: irinotecan hydrochloride Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
Study Start Date : November 2004
Primary Completion Date : November 2008
Study Completion Date : November 2008


Arms and Interventions

Arm Intervention/treatment
Experimental: Irinotecan Drug: irinotecan hydrochloride


Outcome Measures

Primary Outcome Measures :
  1. Response rate [ Time Frame: Every 2 cycles ]
    To determine the response rate of this regimen of irinotecan in patients with metastatic MTC


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Arlene A. Forastiere, MD Sidney Kimmel Comprehensive Cancer Center
More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00100828     History of Changes
Other Study ID Numbers: JHOC-J0459, CDR0000409567
P50CA096784 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0459
JHOC-04080402
First Posted: January 7, 2005    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
thyroid gland medullary carcinoma
recurrent thyroid cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Thyroid Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Diseases
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action