Sorafenib tosilato nel trattamento di pazienti con carcinoma tiroideo localmente avanzato, metastatico o localmente ricorrente

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