A Phase II Evaluation of Cediranib (Recentin; AZD2171, IND# 72740, NSC# 732208) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
PRIMARY OBJECTIVES:
I. To determine the response at 6 months of patients with persistent or recurrent
endometrial carcinoma treated with cediranib maleate.
II. To determine the progression-free survival at 6 months of patients treated with this
regimen.
III. To determine the frequency and degree of toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival of patients treated with this
regimen.
II. To determine the duration of overall survival of patients treated with this regimen.
III. To estimate the probability of response without restriction on the duration of response
documentation of these patients since study enrollment.
TERTIARY OBJECTIVES:
I. To determine whether the response to cediranib maleate correlates with high-expression of
its receptor targets (e.g., VEGFR [1, 2, 3] and PDGFR).
II. To determine whether the response to cediranib maleate correlates with high endogenous
circulating plasma levels of VEGFA, low-levels of its endogenous inhibitor, sFlt-1 (the
truncated, circulating portion of VEGFR-1), or circulating Tissue Factor (TF) or circulating
Par-4, both potential markers of tumor progression.
III. To determine whether a high-expression of VEGFA on pre-treatment tumor specimens
correlates with response to this regimen.
IV. To determine whether expression of phosphorylated ERK1 and 2, c-Jun, Stat3, PKC, and
p70S6 kinase correlates with resistance or sensitivity to cediranib maleate.
OUTLINE: This is a multicenter study.
Patients receive oral cediranib maleate once daily on days 1-28. Treatment repeats every 28
days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection at baseline and periodically
during study for biomarker and other analysis.
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1
At 6 months
No
David Bender
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2011-02043
NCT01132820
June 2010
Name | Location |
---|---|
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Tacoma General Hospital | Tacoma, Washington 98405 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Sarasota Memorial Hospital | Sarasota, Florida 34239 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Group Health Cooperative | Seattle, Washington 98112 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |
Duke University Medical Center | Durham, North Carolina 27710 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Northwest Hospital | Seattle, Washington 98133 |
Virginia Commonwealth University | Richmond, Virginia |
Central Georgia Gynecologic Oncology | Macon, Georgia 31201 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Harrison Medical Center | Bremerton, Washington 98310 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Kettering Medical Center | Kettering, Ohio 45429 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
University of Missouri - Ellis Fischel | Columbia, Missouri 65203 |
Maine Medical Center-Bramhall Campus | Portland, Maine 04102 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View, California 94040 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
The Women's Institute for Gynecologic Cancer and Special Pelvic Surgery | Phillipsburg, New Jersey 08865 |
PeaceHealth Medical Group PC | Bellingham, Washington 98226 |
Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon, Washington 98274 |
Olympic Medical Cancer Care Center | Sequim, Washington 98384 |
Rockwood Cancer Treatment Center | Spokane, Washington 99204 |
Providence Saint Mary Regional Cancer Center | Walla Walla, Washington 99362 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
Mercy Cancer Center-West Lakes | Clive, Iowa 50325 |
Mercy Medical Center-West Lakes | West Des Moines, Iowa 50266 |