局所進行性、転移性、または局所再発甲状腺がん患者の治療におけるトシル酸ソラフェニブ

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