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Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer Clinical research trials and Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer. Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer  Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer
Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer
For Condition: anaplastic thyroid cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Phase I/II trial to study the effectiveness of induction chemotherapy using doxorubicin and cisplatin followed by radiation therapy combined with combretastatin A4 phosphate in treating patients who have newly diagnosedregionally advanced anaplastic thyroid cancer.
Details: OBJECTIVES: Primary - Determine the objective response rate in patients with newly diagnosed regionally advanced anaplastic thyroid cancer treated with induction chemotherapy comprising doxorubicin and cisplatin followed by combretastatin A4 phosphate (CA4P) and radiotherapy. - Determine whether this regimen alters the natural history of anaplastic thyroid cancer by virtue of doubling the median survival of these patients from 10 to 20 months. Secondary - Determine a tolerable dose of CA4P when administered with radiotherapy in these patients. - Determine the safety profile of this regimen in these patients. - Determine clinical predictors of response (e.g., pretreatment tumor microvessel density and immature vessel staining, changes in sICAM-1 levels and tumor blood flow, and pharmacokinetic parameters) in patients treated with this regimen. - Correlate the diminution in blood flow with tumor pain and response in patients treated with this regimen. OUTLINE: This is a multicenter, limited dose-escalation study of combretastatin A4 phosphate (CA4P). - Induction phase: Patients receive doxorubicin IV over 5-10 minutes and cisplatin IV over 30-60 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 3-21 or pegfilgrastim SC on day 2. - Beginning on day 22, patients undergo radiotherapy twice daily, 5 days a week, for 3-4 weeks. Patients also receive CA4P IV over 10 minutes weekly on the fifth day of radiotherapy. 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. - Consolidation phase: Beginning 4-6 weeks after the completion of the combined modality phase, patients receive CA4P IV over 10 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed anaplastic or poorly differentiated variant thyroid carcinoma of either of the following: - Regionally advanced disease - Confined to the neck and/or superior mediastinum (i.e., above the level of the carina) - Measurable or evaluable* disease - Completely resected disease without measurable or evaluable disease NOTE: *At a minimum, abnormalities on physical exam or radiographic studies that may not be precisely measured but readily followed - Must have original/diagnostic tumor blocks available to confirm histopathology and for tumor microvessel density immunohistochemistry - Patients with no available original/diagnostic tumor blocks must have tumor accessible for pretreatment needle core biopsy - Must undergo indirect and direct laryngoscopy to ensure patency of the trachea/airway if deemed inoperable, with bulky thyroid/neck masses and/or suspicion of airway obstruction - No distant metastases, including but not limited to, brain metastases, disease below the level of the carina, pulmonary parenchyma, and hepatic or bony metastases - Superior mediastinal disease (i.e., above the level of the carina) in addition to regional neck disease is allowed provided the disease can be contained in a single radiotherapy port PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute granulocyte count 1,500/mm^3 - Platelet count 75,000/mm^3 - Hemoglobin 8.5 g/dL Hepatic - Bilirubin 1.5 mg/dL - ALT and AST 3.5 times upper limit of normal Renal - Creatinine 1.5 mg/dL Cardiovascular - LVEF 50% by MUGA - EKG normal - No prior angina - No prior myocardial infarction (e.g., significant Q waves), QTc > 450 msec, or other clinically significant abnormalities on ECG - No congestive heart failure - No uncontrolled atrial arrhythmias or clinically significant arrhythmias, including any of the following: - Conduction abnormality - Nodal junctional arrhythmias and dysrhythmias - Sinus bradycardia or tachycardia - Supraventricular arrhythmias - Atrial fibrillation or flutter - Syncope or vasovagal episodes - No significant heart wall abnormality or heart muscle damage by MUGA - No uncontrolled hypertension (i.e., blood pressure consistently greater than 150/100 mm Hg irrespective of medication) - Hypertension is allowed provided there is clinical documentation of controlled blood pressure for 2 months before study entry - No symptomatic peripheral vascular disease or cerebrovascular disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled hypokalemia or hypomagnesemia - No concurrent serious infection - No other nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of study therapy - No grade 2 or greater pre-existing motor or sensory peripheral neuropathy - No psychiatric disorder or other condition that would preclude study compliance - No conditions associated with QTc prolongation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic therapy - No concurrent immunotherapy Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy, except for the following: - Gonadotropin-releasing hormone agonists for patients with hormone-refractory prostate cancer - Hormone replacement therapy - Oral contraceptives - Megestrol for anorexia/cachexia Radiotherapy - No prior radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - Prior attempt at resection or cytoreduction (e.g., debulking) surgery irrespective of surgical margins allowed provided there are no distant metastases - At least 1 week but no more than 8 weeks since prior surgery and recovered Other - No other concurrent cytotoxic therapy - No other concurrent antineoplastic therapy - No other concurrent investigational therapy - No concurrent medications known to prolong the QTc interval unless the medication can be held for at least 4 days during each treatment course
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScotRemick, Study Chair, Ireland Cancer Center
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15213-3489
United States
Recruiting Sanjiv Agarwala 412-648-6507
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Scot Remick 216-844-5412
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Robert Chapman 313-916-1850
Additional Information:
Study ID Numbers: CDR0000349497; CWRU-040337,OXIGENE-CWRU-3302,CWRU-3302
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077103
Other Anaplastic Thyroid Cancer Studies:
1. Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer
2. Combretastatin A4 Phosphate in Treating Patients With Advanced Anaplastic Thyroid Cancer
Related Studies:
Other anaplastic thyroid cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Induction Chemotherapy Using Doxorubicin and Cisplatin Followed by Combretastatin A4 Phosphate and Radiation Therapy in Treating Patients With Newly Diagnosed Regionally Advanced Anaplastic Thyroid Cancer
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