NCT00060242

Combretastatin A4 Phosphate in Treating Patients With Advanced Anaplastic Thyroid Cancer

Phase II Trial Of Combretastatin A-4 Phosphate (CA4P) In Advanced Anaplastic Carcinoma Of The Thyroid

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	fosbretabulin disodium	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.

Timeline

• Start date: 2003-02-01
• Primary completion: 2007-02-01
• Completion: 2008-01-01
• First posted: 2003-05-07
• Last updated: 2010-06-11

Locations

3 sites across 1 country: United States