Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: irinotecan hydrochloride

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0942
      • University of Michigan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Irinotecan	Drug: irinotecan hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate	To determine the response rate of this regimen of irinotecan in patients with metastatic MTC	Every 2 cycles

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: January 6, 2005
• First Submitted That Met QC Criteria: January 6, 2005
• First Posted (Estimate): January 7, 2005

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: thyroid gland medullary carcinoma; recurrent thyroid cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: J0459; P30CA006973 (U.S. NIH Grant/Contract); P50CA096784 (U.S. NIH Grant/Contract); JHOC-J0459; JHOC-04080402; CDR0000409567 (Other Identifier: other); 04-08-04-02 (Other Identifier: JHM IRB)