Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Thyroid Gland Anaplastic Carcinoma

In brief

This randomized phase II trial studies the side effects and how well intensity-modulated radiation therapy (IMRT) and paclitaxel with or without pazopanib hydrochloride works in treating patients with anaplastic thyroid cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and paclitaxel are more effective when given with pazopanib hydrochloride in treating thyroid cancer.

Key facts

Study ID

NCT01236547

Run by

National Cancer Institute (NCI)

People needed

123

Starts

2010-10-28

Expected to finish

2022-05-20

Last updated by the study team

2022-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (histologically or cytologically) proven diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be "consistent with anaplastic thyroid cancer" with the presence of a thyroid mass is acceptable)
• Note: Tissue collection for central review is mandatory, but central review is not required for eligibility; due to the aggressiveness of this disease, treatment will be started prior to central review
• If there was a total or partial thyroidectomy completed within 3 months of enrollment, the surgical specimen must show the area of anaplastic thyroid cancer to be at least 1 cm in greatest dimension
• The following minimum diagnostic workup is required:
• History/physical examination within 2 weeks prior to registration
• Imaging of neck and brain (computed tomography [CT] scan or magnetic resonance imaging [MRI]) and chest/abdominal imaging (chest x-ray or chest CT scan, or full body positron emission tomography [PET]/CT are acceptable) within 4 weeks prior to registration
• Note: The CT scan of the neck must be done with contrast or if an MRI is done, with gadolinium; therefore, the CT portion of a full body PET/CT has to be a high resolution CT to be acceptable for eligibility
• Abdominal imaging must cover the liver and adrenal glands; therefore, separate imaging is not required if these areas are covered by a chest CT scan
• Electrocardiogram within 10 days prior to registration
• Zubrod performance status 0-2
• Absolute neutrophil count (ANC) >= 1,500 cells/mm\^3 (within 10 days prior to registration on study)
• Platelets >= 100,000 cells/mm\^3 (within 10 days prior to registration on study)
• Hemoglobin (Hgb) >= 9.0 g/dl (within 10 days prior to registration on study) (Note: the use of transfusion or other intervention to achieve Hgb >= 9.0 g/dL is acceptable)
• Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (except for patients with Gilbert's syndrome and elevations of indirect bilirubin) (within 10 days prior to registration)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x institutional ULN (within 10 days prior to registration); Note: patients who have both bilirubin > ULN and AST/ALT > ULN are not eligible (unless they have Gilbert's syndrome and elevations of indirect bilirubin)
• Spot urine protein to creatinine ratio (UPCR) < 1 or a 24-hour urine protein collection < 1 gm within 10 days prior to registration
• Creatinine < 1.5 mg/dL or within normal institutional limits within 10 days prior to registration; Note: if neither criteria is met, the creatinine clearance must be > 50 mL/min/1.73 m\^2 per either the Cockcroft-Gault equation, Jeliffe method, or 12- or 24-hour urine collection
• Serum electrolytes including sodium, potassium, blood urea nitrogen (BUN), creatinine, glucose, magnesium, phosphate, and calcium within 10 days prior to registration
• Documentation of the patient's history of corrected QT interval (QTc) prolongation, family history of prolonged QTc, and relevant cardiac disease within 10 days prior to registration
• Evaluation of the patient's medications within 10 days prior to registration with attempt to change any medication that affects cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
• Blood pressure =< 140/90 within 10 days of registration (must be taken and recorded by a health care professional); Note: if the systolic blood pressure is > 140 and/or diastolic blood pressure is > 90 at the time of registration, the patient's blood pressure must be controlled; systolic blood pressure must be < 140 and diastolic blood pressure must be < 90 on at least 2 separate measurements prior to the start of treatment, and the treating physician must believe that this is feasible in order to enroll the patient
• Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal within 10 days prior to registration unless the patient is receiving coumadin and has a stable INR that is in range for the desired level of anticoagulation
• Negative pregnancy test (serum or urine) within 10 days of registration in women of child-bearing potential
• Women of childbearing potential and male participants who are sexually active must agree to practice adequate contraception during treatment and for 6 months post-treatment
• The patient must provide study specific informed consent prior to study entry

You may not qualify if…

• Known active invasive malignancy (except for non-melanomatous skin cancer or anaplastic thyroid cancer; the presence of prostate cancer confined to the prostate with a prostate-specific antigen [PSA] =< 1 ng/mL for more than 6 months also is allowed)
• Prior systemic chemotherapy for anaplastic thyroid cancer
• Patients who have had chemotherapy or radiotherapy within 4 weeks of registration (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered > 4 weeks previously
• Patients receiving other investigational agents
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Patients with any of the following cardiovascular conditions within the past 6 months:
• Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• Admission for unstable angina
• Myocardial Infarction
• Cardiac angioplasty or stenting
• Coronary artery bypass graft surgery
• Pulmonary embolism, untreated deep venous thrombosis (DVT), or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks
• Arterial thrombosis
• Symptomatic peripheral vascular disease
• Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Note: a patient who has a history of class III heart failure and is asymptomatic on treatment may be considered eligible for the study
• Certain medications that are associated with a risk for QTc prolongation and/or torsades de pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
• Patients who require heparin (other than low-molecular weight heparin)
• Patients with any condition that may impair the ability to absorb oral medications/investigational product including:
• Prior surgical procedures affecting absorption including, but not limited to, major resection of stomach or small bowel
• Active peptic ulcer disease
• Malabsorption syndrome
• Patients with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:
• Active peptic ulcer disease
• Known intraluminal metastatic lesions
• Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation

Where it is running

• The Kirklin Clinic at Acton Road — Birmingham, Alabama, United States
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Arizona Oncology-Deer Valley Center — Phoenix, Arizona, United States
• Arizona Oncology Services Foundation — Scottsdale, Arizona, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Vacaville — Vacaville, California, United States
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
• Christiana Gynecologic Oncology LLC — Newark, Delaware, United States
• Delaware Clinical and Laboratory Physicians PA — Newark, Delaware, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Beebe Health Campus — Rehoboth Beach, Delaware, United States
• Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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