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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610206
• Other study ID #: 16153
• Status: Completed
• Phase: Phase 2
• Start date: September 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 31, 2020
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	Duke University	Durham	North Carolina
United States	MD Anderson	Houston	Texas
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Stephenson Cancer Center University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Maine Medical Center (MMP Women's Health)	Scarborough	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Linda R Duska	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	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.	3 years
Secondary	Number of Participants With Adverse Events	Adverse events will be evaluated using CTCAE criteria from the start of study treatment until 30 days following the last dose of study treatment	30 days after last dose