Research & Trial Information
Protocol #: A091305
Cancer Type: Head and Neck Thyroid
- Patients must have histologically or cytologically diagnosed advanced ATC.
- Patients must have Measurable disease.
- Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB).
- Patients should have resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade 1.
- There is no limit to the number of prior lines of treatment a patient has received.
- No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) ≤ 21 days before study registration.
- No prior taxane therapy ≤ 6 months, except as a radiosensitizer.
- No history of the following:• Class III or IV congestive heart failure (CHF).
• Grade 3 or 4 thromboembolic event < 6 months.
• Pericardial effusion < 12 months (any grade).
• Pericardial involvement with tumor.
• Grade 2 or higher pleural effusion < 6 months.
- No current symptomatic, untreated, or uncontrolled brain metastases present.
- No major surgery < 14 days prior to registration.
- No grade 2 or higher neuropathy.
- No known history of severe hypersensitivity reactions to any of the components of efatutazone or paclitaxel formulations.
- Age ≥ 18 years.
- Concomitant Medications:• Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible.
• Patients with known hypersensitivity to any TZD oral agents are not eligible.
- ECOG Performance Status ≤2.