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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Virginia
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Linda R Duska, University of Virginia
ClinicalTrials.gov Identifier:
NCT01610206
First received: May 30, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Drug: Gemcitabine
Drug: pazopanib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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:
  • Adverse events [ Time Frame: 30 days after last dose ] [ Designated as safety issue: Yes ]
    Adverse events will be evaluated using CTCAE criteria from the start of study treatment until 30 days following the last dose of study treatment


Estimated Enrollment: 142
Study Start Date: September 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610206

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda R. Duska, MD    434-924-5100    lduska@virginia.edu   
Principal Investigator: Linda R Duska, MD         
Sponsors and Collaborators
Linda R Duska
GlaxoSmithKline
Investigators
Study Director: Linda Duska, MD University of Virginia School of Medicine
  More Information

No publications provided

Responsible Party: Linda R Duska, Associate Professor, Division of Gynecology Oncology, University of Virginia, University of Virginia
ClinicalTrials.gov Identifier: NCT01610206     History of Changes
Other Study ID Numbers: 16153
Study First Received: May 30, 2012
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
recurrent
persistent

Additional relevant MeSH terms:
Peritoneal Diseases
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Fallopian Tube Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 28, 2014