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

Phase 2

Completed

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cancer
• Interventions: Drug: Gemcitabine; Drug: pazopanib

• Registration Number: NCT01610206
• Lead Sponsor: Linda R Duska

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-01
• Study Start: 2012-09
• Primary Completion: 2018-06-01
• Results First Submitted: 2020-03-06
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Results First Posted: 2021-02-25
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine + pazopanib	Gemcitabine	-
gemcitabine	Gemcitabine	-
Gemcitabine + pazopanib	pazopanib	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	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

Name	Time	Method
Number of Participants With Adverse Events	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

Trial Locations

Locations (8)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Maine Medical Center (MMP Women's Health); 🇺🇸 Scarborough, Maine, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

MD Anderson; 🇺🇸 Houston, Texas, United States

Stephenson Cancer Center University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States