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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Linda Duska, MD

Investigator Role:

Study Director

Investigator Affiliation:

University of Virginia School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

16153

NCT ID:

NCT01610206

Start Date:

September 2012

Completion Date:

July 2018

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • recurrent
  • persistent
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

University of VirginiaCharlottesville, Virginia  22908