Combretastatin A4 Phosphate in Treating Patients With Advanced Anaplastic Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT00060242|
Recruitment Status : Completed
First Posted : May 7, 2003
Last Update Posted : June 11, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: fosbretabulin disodium||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Of Combretastatin A-4 Phosphate (CA4P) In Advanced Anaplastic Carcinoma Of The Thyroid|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||January 2008|
- 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.Other Name: Combretastatin A4 phosphate
- Median survival [ Time Frame: every 8 weeks ]
- Objective disease response [ Time Frame: every 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060242
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Ohio|
|Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Pennsylvania|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|Study Chair:||Panayiotis Savvides, MD||Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center|