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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077103 |
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 |
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Head and Neck Cancer |
Drug: cisplatin Drug: combretastatin A4 phosphate Drug: doxorubicin hydrochloride Drug: filgrastim Drug: pegfilgrastim Procedure: 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)
Cohorts of 6 patients receive 1 of 2 escalating doses of CA4P to determine a tolerable dose. The tolerable dose is defined as the dose at which less than 2 of 6 patients experience dose-limiting toxicity. (Phase I portion of the study closed as of 5/6/04; patients now receive a fixed dose of CA4P)
Treatment in all phases continues in the absence of disease progression or unacceptable toxicity.
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.
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
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 |
Study ID Numbers: | CDR0000349497, CASE-CWRU-3302, CWRU-040337, OXIGENE-CWRU-3302, CASE-3302 |
Study First Received: | February 10, 2004 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00077103 |
Health Authority: | United States: Federal Government |
anaplastic thyroid cancer |
Cisplatin Thyroid Neoplasms Head and Neck Neoplasms Endocrine System Diseases Endocrinopathy Combretastatin A-4 |
Combretastatin Doxorubicin Thyroid cancer, anaplastic Thyroid Diseases Endocrine Gland Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Antibiotics, Antineoplastic Pharmacologic Actions |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |