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

NCT01610206 | Completed Phase 2 Results DMC

• 1 other identifier: 16153
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 8

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

Keywords

recurrent; persistent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Adverse Events

  30 days after last dose

Study Arms (2)

gemcitabine

ACTIVE COMPARATOR

Drug: Gemcitabine

Gemcitabine + pazopanib

EXPERIMENTAL

Drug: Gemcitabine; Drug: pazopanib

Interventions

Gemcitabine 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.

Also known as: gemzar

Gemcitabine + pazopanib; gemcitabine

pazopanib DRUG

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

Also known as: votrient

Gemcitabine + pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linda R Duska: lead
• Novartis: collaborator

Study Sites (8)

Maine Medical Center (MMP Women's Health)

Scarborough, Maine, 04074, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Stephenson Cancer Center University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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.

  PMID: 37185961 DERIVED

• 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.

  PMID: 32247603 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Recurrence

Interventions

Gemcitabine; pazopanib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Our study is limited by lack of placebo control, independent pathology and radiologic review, and correlative science. We did not collect data regarding quality of life, and the study was performed in an unselected patient population.

Results Point of Contact

• Title: Linda Duska, MD
• Organization: University of Virginia

lrd5d@virginia.edu

434-982-1719

Study Officials

• Linda Duska, MD

  University of Virginia School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Division of Gynecology Oncology, University of Virginia

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: December 31, 2020
• Last Updated: February 25, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-02

Locations

US (8)