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Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring thyroid gland medullary carcinoma, recurrent thyroid cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • University of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irinotecan

Arm Description

Outcomes

Primary Outcome Measures

Response Rate
To determine the response rate of this regimen of irinotecan in patients with metastatic MTC

Secondary Outcome Measures

Full Information

First Posted
January 6, 2005
Last Updated
November 12, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00100828
Brief Title
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Official Title
Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Closed due to early stopping rule
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
thyroid gland medullary carcinoma, recurrent thyroid cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irinotecan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Primary Outcome Measure Information:
Title
Response Rate
Description
To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
Time Frame
Every 2 cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene A. Forastiere, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.gov/clinicaltrials
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

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