Efatutazone With Paclitaxel Versus Paclitaxel Alone in Treating Patients With Advanced Anaplastic Thyroid Cancer
Conditions
Anaplastic Thyroid Cancer - Recurrent Thyroid Cancer
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: efatutazone Type: Drug
Name: paclitaxel Type: Drug
Overall Status
Recruiting
Summary
This randomized phase II trial studies how well efatutazone with paclitaxel compared to paclitaxel alone works in treating patients with advanced anaplastic thyroid cancer. Drugs used in chemotherapy, such as efatutazone 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. It is not yet known whether efatutazone in combination with paclitaxel is more effective than paclitaxel alone in treating patients with advanced anaplastic thyroid cancer.
Detailed Description
This is a Phase 2 randomized study of efatutazone with paclitaxel compared to paclitaxel alone. Patients are randomized to one of two treatment arms, efatutazone in combination with paclitaxel or paclitaxel alone. Protocol therapy will consist of continuous cycles administered every 21 days. Treatment will continue until disease progression, unacceptable adverse events, or a minimum of two cycles beyond a complete response. The primary and secondary objectives are listed below.

Primary objective:

To determine if the combination of paclitaxel and efatutazone improves overall survival (OS) compared to paclitaxel alone in patients with advanced anaplastic thyroid cancer.

Secondary objective:

To compare the confirmed response rate, duration of response, progression-free survival (PFS), and adverse event rates between the combination of paclitaxel and efatutazone vs. paclitaxel alone.

Patients will be followed for every 6 months until 5 years after registration.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 1. Documentation of Disease - Patients must have histologically or cytologically diagnosed advanced anaplastic thyroid cancer (ATC).

2. Patients must have measurable disease as defined in the protocol.

3. Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB).

4. 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) ≤ 28 days before study registration.

- No prior taxane therapy ≤ 6 months, except as a radiosensitizer.

5. 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

6. No current symptomatic, untreated, or uncontrolled brain metastases present

7. No major surgery ≤ 28 days prior to registration

8. No grade 2 or higher neuropathy

9. No known history of severe hypersensitivity reactions to any of the components of efatutazone or paclitaxel formulations

10. 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

11. Age ≥ 18 years

12. 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.

13. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

14. Required Initial Laboratory Values:

- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3

- Platelet Count ≥ 100,000/mm3

- Creatinine ≤ 1.5 x ULN (Upper Limit of Normal) mg/dL OR

- Calculated Creatinine Clearance ≥ 60 mL/min

- Bilirubin ≤ 1.5 x ULN

- Aspartate aminotransferase (AST) ≤ 2.5 x ULN
Locations
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Status: Recruiting
Contact: Robert Smallridge, MD - 904-953-2392
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Beebe Medical Center
Lewes, Delaware, United States
Status: Recruiting
Contact: Stephen Grubbs, MD - 302-366-1200
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Status: Recruiting
Contact: Stephen Grubbs, MD - 302-366-1200
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States
Status: Recruiting
Contact: Stephen Grubbs, MD - 302-366-1200
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Status: Recruiting
Contact: Stephen Grubbs, MD - 302-366-1200
Helen F Graham Cancer Center
Newark, Delaware, United States
Status: Recruiting
Contact: Stephen Grubbs, MD - 302-366-1200
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Status: Recruiting
Contact: Stephen Grubbs, MD - 302-366-1200
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Status: Recruiting
Contact: Stephen Grubbs, MD - 302-366-1200
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Status: Recruiting
Contact: Stephen Grubbs, MD - 302-366-1200
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Status: Recruiting
Contact: Stephen Grubbs, MD - 302-366-1200
Mayo Clinic in Florida
Jacksonville, Florida, United States
Status: Recruiting
Contact: Robert Smallridge, MD - 904-953-2392
Oncare Hawaii Inc. - Pali Momi
Aiea, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
Pali Momi Medical Center
Aiea, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
Kuakini Medical Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
OnCare Hawaii - Liliha
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
Oncare Hawaii Inc - POB II
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
Oncare Hawaii Inc. - Kuakini
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
Queen's Medical Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
Straub Clinic and Hospital
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Status: Recruiting
Contact: Jeffrey Berenberg, MD - 808-586-2979
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Independence
Independence, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Liberal
Liberal, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Associates In Womens Health
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Wichita Medical Arts Tower
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Via Christi Regional Medical Center
Wichita, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Status: Recruiting
Contact: Shaker Dakhil, MD - 316-262-4467
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Henry Ford Hospital
Detroit, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Hurley Medical Center
Flint, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Allegiance Health
Jackson, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Sparrow Hospital
Lansing, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Saint Mary's of Michigan
Saginaw, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Status: Recruiting
Contact: Tareq Al Baghdadi, MD - 734-712-1000
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Robert Smallridge, MD - 904-953-2392
Central Care Cancer Center - Carrie J Babb Cancer Center
Bolivar, Missouri, United States
Status: Recruiting
Contact: Jay Carlson, MD - 417-820-3554
Freeman Health System
Joplin, Missouri, United States
Status: Recruiting
Contact: Jay Carlson, MD - 417-820-3554
Phelps County Regional Medical Center
Rolla, Missouri, United States
Status: Recruiting
Contact: Jay Carlson, MD - 417-820-3554
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Jay Carlson, MD - 417-820-3554
Saint Louis Cancer and Breast Institute - South City
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Jay Carlson, MD - 417-820-3554
Washington University School of Medicine
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Douglas Adkins, MD - 314-362-5654
Cox Health South Hospital
Springfield, Missouri, United States
Status: Recruiting
Contact: Jay Carlson, MD - 417-820-3554
Mercy Hospital Springfield
Springfield, Missouri, United States
Status: Recruiting
Contact: Jay Carlson, MD - 417-820-3554
University of Cincinnati
Cincinnati, Ohio, United States
Status: Recruiting
Contact: Nooshin Hashemi-Sadraei, MD - 513-558-2158
University Pointe
West Chester, Ohio, United States
Status: Recruiting
Contact: Nooshin Hashemi-Sadraei, MD - 513-558-2158
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Mohammad Razaq, MD - 405-271-8777
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Status: Recruiting
Contact: Mohammad Razaq, MD - 405-271-8777
Start Date
September 2014
Sponsors
Alliance for Clinical Trials in Oncology
Source
Alliance for Clinical Trials in Oncology
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page