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A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01610206
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : February 25, 2021
Last Update Posted : February 25, 2021
Information provided by (Responsible Party):
Linda R Duska, University of Virginia

Brief Summary:
Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib is a novel agent has recently been approved for the treatment of subjects with advanced renal cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for recurrent or persistent ovarian cancer. This is an open label study in which subjects will be randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib. Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle. Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All subjects will be monitored for toxicity and other indicators of safety (labs, physical exams, vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5 years following the conclusion of treatment to evaluate efficacy. The primary endpoints of the study are progression free survival and overall survival, which will be assessed at three years.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: Gemcitabine Drug: pazopanib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Open Label Phase II Study of Weekly Gemcitabine Plus Pazopanib Versus Weekly Gemcitabine Alone in the Treatment of Patients With Persistent or Relapsed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
Actual Study Start Date : September 2012
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: gemcitabine Drug: Gemcitabine
Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
Other Name: gemzar

Experimental: Gemcitabine + pazopanib Drug: Gemcitabine
Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
Other Name: gemzar

Drug: pazopanib
Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
Other Name: votrient

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 3 years ]
    Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of recurrence/progression or death from any cause, whichever occurs first.

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 30 days after last dose ]
    Adverse events will be evaluated using CTCAE criteria from the start of study treatment until 30 days following the last dose of study treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be at least 18 years old
  • Must have measurable or detectable ovarian, fallopian or primary peritoneal cancer
  • Must have been treated previously with carboplatin, cisplatin or another organoplatinum compound

Exclusion Criteria:

  • Women who are pregnant or nursing
  • History of congenital long QT syndrome
  • Active bleeding or at risk of a bleeding disorder
  • Other significant medical condition or history of medical condition which may put the patient at risk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01610206

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United States, Maine
Maine Medical Center (MMP Women's Health)
Scarborough, Maine, United States, 04074
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Oklahoma
Stephenson Cancer Center University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
MD Anderson
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Linda R Duska
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Study Director: Linda Duska, MD University of Virginia School of Medicine
  Study Documents (Full-Text)

Documents provided by Linda R Duska, University of Virginia:
Informed Consent Form  [PDF] February 1, 2017

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Linda R Duska, Associate Professor, Division of Gynecology Oncology, University of Virginia, University of Virginia Identifier: NCT01610206    
Other Study ID Numbers: 16153
First Posted: June 1, 2012    Key Record Dates
Results First Posted: February 25, 2021
Last Update Posted: February 25, 2021
Last Verified: February 2021
Keywords provided by Linda R Duska, University of Virginia:
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs