Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 4:40 AM
Study NCT ID:
NCT00077103
Status:
TERMINATED
Last Update Posted:
2010-06-11
First Post:
2004-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D065646', 'term': 'Thyroid Carcinoma, Anaplastic'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C058728', 'term': 'fosbretabulin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-09', 'studyFirstSubmitDate': '2004-02-10', 'studyFirstSubmitQcDate': '2004-02-10', 'lastUpdatePostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median survival', 'timeFrame': 'at months 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 33, and 36'}], 'secondaryOutcomes': [{'measure': 'Objective disease response', 'timeFrame': 'at the end of induction, combined modality therapy, and consolidation therapy, at 2 months after completion of consolidation therapy, at 2 month intervals during year 1, and then 3 month intervals during years 2 and 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anaplastic thyroid cancer'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n* 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.\n\nSecondary\n\n* Determine a tolerable dose of CA4P when administered with radiotherapy in these patients. (Phase I portion of the study closed as of 5/6/04; patients now receive a fixed dose of CA4P)\n* Determine the safety profile of this regimen in these patients.\n* 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.\n* Correlate the diminution in blood flow with tumor pain and response in patients treated with this regimen.\n\nOUTLINE: 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)\n\n* 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.\n* Combined modality phase: 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.\n\nCohorts 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)\n\n* 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.\n\nTreatment in all phases continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 2 months for 1 year and then every 3 months for 2 years from study entry.\n\nPROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed anaplastic or poorly differentiated variant thyroid carcinoma of either of the following:\n\n * Regionally advanced disease\n\n * Confined to the neck and/or superior mediastinum (i.e., above the level of the carina)\n * Measurable or evaluable\\* disease\n * 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\n* Must have original/diagnostic tumor blocks available to confirm histopathology and for tumor microvessel density immunohistochemistry\n\n * Patients with no available original/diagnostic tumor blocks must have tumor accessible for pretreatment needle core biopsy\n* 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\n* No distant metastases, including but not limited to, brain metastases, disease below the level of the carina, pulmonary parenchyma, and hepatic or bony metastases\n\n * 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\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute granulocyte count ≥ 1,500/mm\\^3\n* Platelet count ≥ 75,000/mm\\^3\n* Hemoglobin ≥ 8.5 g/dL\n\nHepatic\n\n* Bilirubin ≤ 1.5 mg/dL\n* ALT and AST ≤ 3.5 times upper limit of normal\n\nRenal\n\n* Creatinine ≤ 1.5 mg/dL\n\nCardiovascular\n\n* LVEF ≥ 50% by echocardiogram\n* EKG normal\n* No prior angina\n* No prior myocardial infarction (e.g., significant Q waves), QTc \\> 450 msec, or other clinically significant abnormalities on ECG\n* No congestive heart failure\n* No uncontrolled atrial arrhythmias or clinically significant arrhythmias, including any of the following:\n\n * Conduction abnormality\n * Nodal junctional arrhythmias and dysrhythmias\n * Sinus bradycardia or tachycardia\n * Supraventricular arrhythmias\n * Atrial fibrillation or flutter\n * Syncope or vasovagal episodes\n* No significant heart wall abnormality or heart muscle damage by echocardiogram\n* No uncontrolled hypertension (i.e., blood pressure consistently greater than 150/100 mm Hg irrespective of medication)\n\n * Hypertension is allowed provided there is clinical documentation of controlled blood pressure for 2 months before study entry\n* No symptomatic peripheral vascular disease or cerebrovascular disease\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No uncontrolled hypokalemia or hypomagnesemia\n* No concurrent serious infection\n* No other nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of study therapy\n* No grade 2 or greater pre-existing motor or sensory peripheral neuropathy\n* No psychiatric disorder or other condition that would preclude study compliance\n* No conditions associated with QTc prolongation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent biologic therapy\n* No concurrent immunotherapy\n\nChemotherapy\n\n* No prior chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* No concurrent hormonal therapy, except for the following:\n\n * Gonadotropin-releasing hormone agonists for patients with hormone-refractory prostate cancer\n * Hormone replacement therapy\n * Oral contraceptives\n * Megestrol for anorexia/cachexia\n\nRadiotherapy\n\n* No prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* Prior attempt at resection or cytoreduction (e.g., debulking) surgery irrespective of surgical margins allowed provided there are no distant metastases\n* At least 1 week but no more than 8 weeks since prior surgery and recovered\n\nOther\n\n* No other concurrent cytotoxic therapy\n* No other concurrent antineoplastic therapy\n* No other concurrent investigational therapy\n* No concurrent medications known to prolong the QTc interval unless the medication can be held for at least 4 days during each treatment course'}, 'identificationModule': {'nctId': 'NCT00077103', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': '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]', 'orgStudyIdInfo': {'id': 'CWRU3302'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE-CWRU-3302', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}, {'id': 'CWRU-040337'}, {'id': 'OXIGENE-CWRU-3302'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'description': 'filgrastim (G-CSF) subcutaneously (SC) on days 3-21 or pegfilgrastim SC on day 2.'}, {'name': 'pegfilgrastim', 'type': 'BIOLOGICAL', 'description': 'filgrastim (G-CSF) subcutaneously (SC) on days 3-21 or pegfilgrastim SC on day 2.'}, {'name': 'cisplatin', 'type': 'DRUG', 'description': 'cisplatin IV over 30-60 minutes on day 1'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'description': 'doxorubicin IV over 5-10 minutes'}, {'name': 'fosbretabulin disodium', 'type': 'DRUG', 'otherNames': ['Combretastatin A-4 Phosphate', 'CA4P'], 'description': 'Combined Modality Phase:Patients also receive CA4P IV over 10 minutes weekly on the fifth day of radiotherapy. 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.'}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'Beginning on day 22, patients undergo radiotherapy twice daily, 5 days a week, for 3-4 weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Josephine Ford Cancer Center at Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hillman Cancer Center at University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Panayiotis Savvides, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Panayiotis Savvides, MD', 'oldOrganization': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}}}}