A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
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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 |
- 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.
- 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 |
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| 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 | |
| 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: | October 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Virginia:
|
recurrent persistent |
Additional relevant MeSH terms:
|
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 Peritoneal 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 May 19, 2013