Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, Peritoneal Cancer, or Recurrent Triple-Negative Breast Cancer



Status:Archived
Conditions:Breast Cancer, Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:March 2010

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Phase I/II Study of Cediranib and Olaparib in Combination for Treatment of Recurrent Platinum-Sensitive Papillary-Serous Ovarian, Fallopian Tube, or Peritoneal Cancer or for Treatment of Recurrent Triple-Negative Breast Cancer


RATIONALE: Cediranib maleate and olaparib may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth. Cediranib maleate may also stop the growth of
tumor cells by blocking blood flow to the tumor. Giving cediranib maleate together with
olaparib may kill more tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and the best dose of
cediranib maleate when given together with olaparib and to see how well they work compared
to cediranib maleate alone in treating patients with recurrent ovarian epithelial cancer,
fallopian tube cancer, peritoneal cancer, or recurrent triple-negative breast cancer.


OBJECTIVES:

Primary

- Assess the maximum-tolerated dose of cediranib maleate in combination with olaparib in
patients with recurrent platinum-sensitive papillary-serous ovarian, fallopian tube, or
peritoneal cancer or metastatic triple-negative breast cancer. (Phase I)

- Assess the efficacy, in terms of progression-free survival (PFS), of cediranib maleate
with versus without olaparib in patients with recurrent grade 2 or 3 platinum-sensitive
papillary-serous ovarian, fallopian tube, or peritoneal cancer. (Phase II)

Secondary

- Assess the toxicity of this regimen in these patients. (Phase I)

- Assess the clinical benefit, PFS, and overall survival of patients treated with this
regimen. (Phase I)

- Assess tumor response, clinical response benefit, and overall survival of patients
treated with these regimens. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a randomized
phase II study.

- Phase I: Patients receive oral cediranib maleate once daily and oral olaparib twice
daily on days 1-28. Treatment repeats every 28 days in the absence of disease
progression or unacceptable toxicity.

- Phase II: Patients are stratified according to prior antiangiogenic therapy (yes vs no)
and BRCA mutation status (carrier vs non-carrier vs unknown). Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients receive oral cediranib maleate once daily on days 1-28.

- Arm II: Patients receive oral cediranib maleate once daily and oral olaparib twice
daily on days 1-28.

In both arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years.


We found this trial at
22
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
(617) 632-3000
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Founded in 1997, Dana-Farber/Harvard Cancer Center (DF/HCC) was...
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Boston, MA
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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Fort Wayne, IN
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Ann Arbor, Michigan 48103
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Annandale, Virginia 22003
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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2300 N. Edward Street
Decatur, Illinois 62526
217-876-8121
Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
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Decatur, IL
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Evanston, Illinois 60201
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Greensboro, North Carolina 27401
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3500 S. Lafountain Street
Kokomo, Indiana 46902
765-453-0702
Community Howard Regional Health Selecting quality health care services for yourself, a relative or friend...
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Kokomo, IN
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8700 Beverly Blvd.
Los Angeles, California 90048
1-800-233-2771
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Cedars-Sinai's Samuel Oschin Comprehensive Cancer Institute...
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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8940 Wood Sage Rd
Peoria, Illinois 61615
(309) 243-3000
Illinois CancerCare-Peoria Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Saint Joseph, Michigan 49085
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Springfield, Illinois 62701
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3850 S National Ave
Springfield, Missouri 65807
(417) 269-5257
Hulston Cancer Center at Cox Medical Center South In 1997, the cancer program at CoxHealth...
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Springfield, MO
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