Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This phase II trial is studying how well sorafenib works in treating patients with advanced anaplastic thyroid cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Full description
OBJECTIVES:
I. Determine whether the objective response rate is ≥ 20% in patients with advanced anaplastic thyroid cancer treated with sorafenib.
II. Determine the survival of patients treated with this drug. III. Determine the safety profile of this drug in these patients. IV. Determine the pharmacokinetic predictors of response to this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for survival.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Criteria:
Progressive disease after prior cytotoxic chemotherapy (i.e., chemotherapy alone or combined with radiotherapy)
No symptomatic bulky disease that would impair the airway or impede swallowing (for patients with ECOG performance status 2)
No known brain metastases
Measurable or evaluable disease
Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible provided disease has been stable for the past 6 months
Performance status:
Life expectancy more than 8 weeks
Absolute neutrophil count >= 1,250/mm3
Platelet count >= 100,000/mm3
No evidence of bleeding diathesis
Bilirubin =< 1.5 times upper limit of normal (ULN)
PTT =< 1.5 times ULN
Creatinine =< 1.5 times ULN
No myocardial infarction within the past 6 months
No New York Heart Association class III or IV cardiac disease
No symptomatic congestive heart failure
No unstable angina pectoris
No uncontrolled hypertension (i.e., systolic blood pressure (BP) > 150 mm Hg OR diastolic BP > 100 mm Hg)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to swallow oral medication
No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
No other uncontrolled illness
No more than 2 prior systemic cytotoxic chemotherapy regimens (combined modality systemic cytoxic chemotherapy is considered 1 prior cytotoxic regimen)
At least 7 days since prior chemotherapy and recovered
At least 7 days since prior radiotherapy and recovered
No prior sorafenib or other inhibitors of MAP kinase signaling intermediates
No prior cancer treatment that would preclude study participation
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
No concurrent Hypericum perforatum (St. John's wort) or rifampin
No concurrent therapeutic anticoagulation (concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided requirements for INR and PTT are met)
No other concurrent anticancer therapy
Histologically confirmed anaplastic* thyroid cancer
No cardiac arrhythmia
AST and ALT =< 3.5 times ULN
INR < 2.0
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal