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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 : Terminated (Closed due to early stopping rule)
First Posted : January 7, 2005
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
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
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008


Arm Intervention/treatment
Experimental: Irinotecan Drug: irinotecan hydrochloride



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
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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 at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Study Chair: Arlene A. Forastiere, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Additional Information:
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00100828    
Other Study ID Numbers: J0459
P50CA096784 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0459
JHOC-04080402
CDR0000409567 ( Other Identifier: other )
04-08-04-02 ( Other Identifier: JHM IRB )
First Posted: January 7, 2005    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: November 2018
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
thyroid gland medullary carcinoma
recurrent thyroid cancer
Additional relevant MeSH terms:
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Thyroid Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents