NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




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.



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Head & Neck Clinical Trial

CANCER TYPE: Head & Neck
RESEARCH BASE: Alliance
NCT NUMBER: NCT02152137
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM
UPDATED ON 09/19/2018 (19:57:25)

BRIEF DESCRIPTION

ANAPLASTIC THYROID, metastatic or locally advanced unresectable; Paclitaxel + Efatutazone vs. Paclitaxel alone.



NOTES


Treatment Plan    (Supplied Drug:  Efatutazone)



ELIGIBILITY

  • 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)





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