Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

Head and Neck Cancer Clinical Trial

Official title:

Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00100828
• Other study ID #: J0459
• Secondary ID: P50CA096784P30CA
• Status: Terminated
• Phase: Phase 2
• Start date: November 2004
• Est. completion date: November 2008

Study information

• Verified date: November 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Thyroid Neoplasms

Intervention

Drug:
• irinotecan hydrochloride

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	To determine the response rate of this regimen of irinotecan in patients with metastatic MTC	Every 2 cycles

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database