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