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| Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077103 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combretastatin A4 phosphate may stop the growth of cancer by stopping blood flow to the tumor. Combining doxorubicin and cisplatin with radiation therapy and combretastatin A4 phosphate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving induction chemotherapy using doxorubicin and cisplatin together with radiation therapy and combretastatin A4 phosphate works in treating patients with newly diagnosed regionally advanced anaplastic thyroid cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: combretastatin A4 phosphate Drug: doxorubicin hydrochloride Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial of Combined Modality Combretastatin A-4 Phosphate (CA4P)-Based Therapy for Patients With Newly Diagnosed Anaplastic Thyroid Cancer [Induction Chemotherapy With Doxorubicin/Cisplatin; Combined Modality Therapy With CA4P and Radiation; Followed by 2 Cycles of CA4P Consolidation] |
| Estimated Enrollment: | 33 |
| Study Start Date: | November 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study of combretastatin A4 phosphate (CA4P). (Phase I portion of the study closed as of 5/6/04; patients now receive a fixed dose of CA4P)
Patients are followed every 2 months for 1 year and then every 3 months for 2 years from study entry.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 18 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 carcinoma of either of the following:
Regionally advanced disease
Must have original/diagnostic tumor blocks available to confirm histopathology and for tumor microvessel density immunohistochemistry
No distant metastases, including but not limited to, brain metastases, disease below the level of the carina, pulmonary parenchyma, and hepatic or bony metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No uncontrolled atrial arrhythmias or clinically significant arrhythmias, including any of the following:
No uncontrolled hypertension (i.e., blood pressure consistently greater than 150/100 mm Hg irrespective of medication)
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy, except for 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: | CDR0000349497, CASE-CWRU-3302, CWRU-040337, OXIGENE-CWRU-3302, CASE-3302 |
| Study First Received: | February 10, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00077103 History of Changes |
| Health Authority: | United States: Federal Government |
|
anaplastic thyroid cancer |
|
Thyroid Neoplasms Endocrine System Diseases Antimitotic Agents Combretastatin Doxorubicin Anti-Bacterial Agents Cisplatin Radiation-Sensitizing Agents |
Head and Neck Neoplasms Tubulin Modulators Thyroid Cancer, Anaplastic Endocrinopathy Antineoplastic Agents, Phytogenic Combretastatin A-4 Thyroid Diseases Endocrine Gland Neoplasms |
|
Molecular Mechanisms of Pharmacological Action Thyroid Neoplasms Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Endocrine System Diseases Antimitotic Agents Antibiotics, Antineoplastic Combretastatin Pharmacologic Actions Doxorubicin |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Head and Neck Neoplasms Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Combretastatin A-4 Thyroid Diseases Endocrine Gland Neoplasms |