Anaplastic Thyroid Cancer Clinical Trial
Official title:
Phase II Trial of BAY 43-9006 in Patients With Advanced Anaplastic Carcinoma of the Thyroid
Verified date | December 2017 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 - Measurable disease, defined as = 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan - Measurable disease not in a previously irradiated field - 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: - ECOG 0-2 OR Karnofsky 50-100% - 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 - Not amenable to definitive curative surgery or radiotherapy [Note: *Papillary, follicular, or other histologies that are mixed or identified in a diagnostic tissue sample are allowed provided a high-grade undifferentiated anaplastic component is present ] - No cardiac arrhythmia - AST and ALT =< 3.5 times ULN - INR < 2.0 |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients With Response to Treatment Measured by RECIST Criteria | Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, x-ray) or as >10 mm with spiral CT scan. | at 6 months after treatment | |
Secondary | Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression. | 27 months | ||
Secondary | Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death. | 27 months | ||
Secondary | Number of Participants That Experienced Adverse Events to Characterize the Safety Profile of BAY 43-9006 | The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events. | 27 months |
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