|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00060242 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: combretastatin A4 phosphate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial Of Combretastatin A-4 Phosphate (CA4P) In Advanced Anaplastic Carcinoma Of The Thyroid |
| Estimated Enrollment: | 32 |
| Study Start Date: | February 2003 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* anaplastic or poorly differentiated variant thyroid cancer, including 1 of the following:
No active brain metastases, as evidenced by any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
EKG normal
No clinically significant arrhythmias, including any of the following:
No uncontrolled hypertension (blood pressure consistently greater than 150 mm Hg systolic and 100 mm Hg diastolic regardless of medication)
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy, except any of the following:
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Michigan | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Ohio | |
| 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: | Scot C. Remick, MD | Case Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000301575, CASE-CWRU-ICC-2302, CASE-2302 |
| Study First Received: | May 6, 2003 |
| Last Updated: | March 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00060242 History of Changes |
| Health Authority: | United States: Federal Government |
|
anaplastic thyroid cancer recurrent thyroid cancer |
|
Thyroid Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Endocrine System Diseases Antimitotic Agents Combretastatin Pharmacologic Actions Neoplasms |
Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Tubulin Modulators Antineoplastic Agents, Phytogenic Combretastatin A-4 Thyroid Diseases Endocrine Gland Neoplasms |