Status:
TERMINATED
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
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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-ray...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate in patients with newly diagnosed regionally advanced anaplastic thyroid cancer treated with induction chemotherapy comprising doxorubicin ...
Eligibility Criteria
Inclusion
- 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 echocardiogram
- 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 echocardiogram
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00077103
Start Date
November 1 2003
End Date
December 1 2007
Last Update
June 11 2010
Active Locations (3)
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1
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
3
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232