Combretastatin A4 Phosphate in Treating Patients With Advanced Anaplastic Thyroid Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00060242
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

RATIONALE: Combretastatin A4 phosphate may stop the growth of anaplastic thyroid cancer by stopping blood flow to the tumor.

PURPOSE: This phase II trial is studying how well combretastatin A4 phosphate works in treating patients with advanced recurrent or metastatic anaplastic thyroid cancer.

Detailed Description

OBJECTIVES:

* Determine the objective response rate of patients with advanced anaplastic thyroid cancer treated with combretastatin A4 phosphate.

* Determine whether this drug alters the natural history of anaplastic thyroid cancer, in terms of doubling the median survival from 4-6 months to 12 months, in these patients.

* Determine the safety profile of this drug in these patients.

* Correlate clinical response with pretreatment tumor microvessel density and immature vessel staining, changes in sICAM-1 levels over the course of treatment, and pharmacokinetic parameters in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive combretastatin A4 phosphate IV over 10 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses beyond documentation of the CR.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 18-24 months.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-05-06
• Study First Submitted QC: 2003-05-06
• Study First Posted: 2003-05-07
• Primary Completion: 2007-02
• Study Completion: 2008-01
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Median survival	every 8 weeks

Secondary Outcome Measures

Name	Time	Method
Objective disease response	every 8 weeks

Trial Locations

Locations (3)

Hillman Cancer Center at University of Pittsburgh Cancer Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Josephine Ford Cancer Center at Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States