Status:
TERMINATED
Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Anaplastic Thyroid Cancer
Insular Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II trial to study the effectiveness of sorafenib tosylate in treating patients who have locally advanced, metastatic, or locally recurrent thyroid cancer. Sorafenib tosylate may stop the growth ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine objective response rate in patients with locally advanced, metastatic, or locally recurrent differentiated thyroid cancer treated with sorafenib (BAY 43-9006). SECON...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed diagnosis of 1 of the following:
- Papillary thyroid cancer (stratum I)
- Papillary, follicular, Hurthle cell, insular, or anaplastic thyroid cancer (stratum II)
- Mixed histology, poorly differentiated, or tall-cell variants allowed
- Metastatic, locally advanced, or locally recurrent disease
- At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
- The following are considered non-measurable disease:
- Tumors in a previously irradiated area
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Archival tumor tissue block OR material collected before study entry available (stratum I)
- Biopsy-accessible disease (stratum I)
- Performance status - ECOG 0-1
- At least 6 months
- WBC \>= 3,000/mm\^3
- Absolute neutrophil count \>= 1,500/mm\^3
- Platelet count \>= 100,000/mm\^3
- No bleeding diathesis
- Bilirubin =\< 1.5 times upper limit of normal (ULN)
- AST and ALT =\< 1.5 times ULN
- Creatinine =\< 1.5 times ULN
- No uncontrolled hypertension
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to undergo 2 tumor biopsies during study participation (stratum I)
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No other concurrent malignancy except nonmetastatic nonmelanoma skin cancer or carcinoma in situ of the cervix
- No prior systemic chemotherapy for thyroid cancer (stratum I)
- Prior systemic chemotherapy used to treat a second primary cancer with curative intent allowed provided the primary cancer was treated more than 5 years before study entry
- No more than 3 prior systemic chemotherapy regimens for thyroid cancer (stratum II)
- More than 6 weeks since prior systemic chemotherapy (stratum II)
- No prior external beam radiotherapy to the sole site of measurable disease (except for patients with anaplastic thyroid cancer)
- More than 6 weeks since prior external beam radiotherapy
- More than 24 weeks since prior iodine I 131
- Recovered from all prior therapy
- No prior sorafenib
- More than 6 weeks since prior investigational tumor-specific therapy
- Concurrent oral or IV bisphosphonates for bony metastases allowed at the discretion of the investigator
- No other concurrent tumor-specific or investigational therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent therapeutic anticoagulation
- Concurrent prophylactic anticoagulation (e.g., low-dose warfarin) for venous or arterial access devices allowed provided PT, INR, or PTT are normal
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00095693
Start Date
October 1 2004
End Date
December 1 2011
Last Update
January 16 2014
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210