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

NCT ID: NCT01610206

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2020-12-31

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

gemcitabine

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

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.

Gemcitabine + pazopanib

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

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.

pazopanib

Intervention Type: DRUG

Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles

Interventions

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.

Intervention Type: DRUG

pazopanib

Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles

Intervention Type: DRUG

Other Intervention Names

gemzar; votrient

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Linda R Duska

OTHER

Sponsor Role: lead

Responsible Party

Linda R Duska

Associate Professor, Division of Gynecology Oncology, University of Virginia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Linda Duska, MD

Role: STUDY_DIRECTOR

University of Virginia School of Medicine

Locations

Maine Medical Center (MMP Women's Health)

Scarborough, Maine, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Duke University

Durham, North Carolina, United States

Stephenson Cancer Center University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

MD Anderson

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

References

Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

Reference Type: DERIVED

PMID: 37185961 (View on PubMed)

Duska LR, Petroni GR, Varhegyi N, Brown J, Jelovac D, Moore KN, McGuire WP, Darus C, Barroilhet LM, Secord AA. A randomized phase II evaluation of weekly gemcitabine plus pazopanib versus weekly gemcitabine alone in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Gynecol Oncol. 2020 Jun;157(3):585-592. doi: 10.1016/j.ygyno.2019.10.014. Epub 2020 Apr 1.

Reference Type: DERIVED

PMID: 32247603 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16153

Identifier Type: -

Identifier Source: org_study_id