NCI Community Oncology Research Program - Protocol Summary
Alliance A091305 - "A Phase 2 Randomized Study Of Efatutazone, An Oral PPAR Agonist, In Combination With Paclitaxel Versus Paclitaxel In Patients With Advanced Anaplastic Thyroid Cancer"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please follow the "Full Protocol" link or contact NCORP-KC for complete protocol information.
Head & Neck Clinical Trial
CANCER TYPE: Head & Neck
RESEARCH BASE: Alliance
NCT NUMBER: NCT02152137
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
ANAPLASTIC THYROID, metastatic or locally advanced unresectable; Paclitaxel + Efatutazone vs. Paclitaxel alone.
Treatment Plan (Supplied Drug: Efatutazone)
- Patients must have histologically or cytologically diagnosed advanced ATC.
- Patients must have Measurable disease as defined in Section 11.0.
- Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB).
- Prior Treatment:
• 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.
- Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
- 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
- Required Initial Laboratory Values:
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- Platelet Count ≥ 100,000/mm3
- Creatinine ≤ 1.5 x ULN mg/dL OR
- Calc. Creatinine Clearance ≥ 60 mL/min
- Bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST ≤ 2.5 x upper limit of normal (ULN)