Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer



Status:Active, not recruiting
Conditions:Cancer, Cancer, Endocrine, Thyroid Cancer
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/7/2018
Start Date:September 2014

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A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination With Paclitaxel in Patients With Advanced Anaplastic Thyroid Cancer

This phase II trial studies how well inolitazone dihydrochloride (efatutazone
dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer that
has spread to other places in the body and usually cannot be cured or controlled with
treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and
paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading.

PRIMARY OBJECTIVES:

I. To determine if the combination of paclitaxel and efatutazone (efatutazone
dihydrochloride) improves the confirmed response rate in patients with advanced anaplastic
thyroid cancer.

SECONDARY OBJECTIVES:

I. To estimate the overall survival (OS), duration of response, progression-free survival
(PFS), and adverse event rates for the combination of paclitaxel and efatutazone.

TERTIARY OBJECTIVES:

I. The association of biomarkers with clinical outcome data will be assessed in an
exploratory translational analysis.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 3 hours on day 1 and efatutazone
dihydrochloride orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 28 days, every 8 weeks
until disease progression, and then every 6 months for 5 years.

- Patients must have histologically or cytologically diagnosed advanced anaplastic
thyroid cancer (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 National Cancer Institute (NCI) Common Terminology Criteria for Adverse
Events (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; women of childbearing potential only, a negative
pregnancy test done =< 7 days prior to registration is required

- 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

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Creatinine =< 1.5 x upper limit of normal (ULN) mg/dL OR calculated (calc.) creatinine
clearance >= 60 mL/min

- Bilirubin =< 1.5 x ULN

- Aspartate aminotransferase (AST) =< 2.5 x ULN

- Although they will not be considered formal eligibility (exclusion) criteria,
physicians should recognize that the following may seriously increase the risk to the
patient entering this protocol:

- Psychiatric illness which would prevent the patient from giving informed consent

- Medical condition such as uncontrolled infection (including human
immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease
which, in the opinion of the treating physician, would make this protocol
unreasonably hazardous for the patient

- Patients with a "currently active" second malignancy other than non-melanoma skin
cancers; patients are not considered to have a "currently active" malignancy if
they have completed therapy and are free of disease for >= 3 years; there is an
exception for patients with a history of well differentiated thyroid cancer that
has progressed to anaplastic thyroid cancer

- Patients who cannot swallow oral formulations of the agent(s)

- Women and men of reproductive potential should agree to use an appropriate method
of birth control throughout their participation in this study ; appropriate
methods of birth control include abstinence, oral contraceptives, implantable
hormonal contraceptives or double barrier method (diaphragm plus condom)

- Efatutazone is metabolized by cytochrome P450, family 3, subfamily A, polypeptide
4/5 (CYP3A4/5), and inhibits CYP2C8, 2C9, 2C19, and 3A4, and is a substrate of
P-glycoprotein (PgP) and breast cancer resistance protein (BCRP)
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New Haven, Connecticut 6520
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701 Grove Rd
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Honolulu, Hawaii 96813
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-586-2979
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Jeffrey L. Berenberg
Phone: 773-702-9171
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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888 S King St
Honolulu, Hawaii 96813
(808) 522-4000
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-522-4333
Straub Clinic And Hospital Founded in 1921, Straub Clinic & Hospital is a fully integrated...
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