Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine Columbia University
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00868192

Sponsors and Collaborators:

Washington University School of Medicine
Columbia University

Information provided by:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT00868192

Purpose

The purpose of this study is to determine if the combination of bevacizumab and pemetrexed have an effect on recurrent ovarian and primary peritoneal carcinoma by looking at progression and survival at 6 months.

Condition	Intervention	Phase
Ovarian Carcinoma Primary Peritoneal Carcinoma	Drug: pemetrexed and bevacizumab combination therapy	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

To determine the anti-tumor activity of the combination of bevacizumab and pemetrexed as measured by progression-free survival in patients with recurrent epithelial ovarian or primary peritoneal carcinoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the distribution of progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To estimate the distribution of overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To determine the toxicity associated with bevacizumab and pemetrexed [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To determine the frequency of clinical response, as assessed by RECIST criteria, to the combination regimen of bevacizumab and pemetrexed [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To correlate patterns of gene expression as assessed by Illumina cDNA mediated annealing, selection, extension and ligation (DASL) microarray from paraffin-embedded tumor specimens with response to pemetrexed and bevacizumab [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
To determine the association between levels of thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyl transferase and ovarian response to pemetrexed and bevacizumab [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pemetrexed and bevacizumab: Experimental	Drug: pemetrexed and bevacizumab combination therapy Pemetrexed 500 mg/m2 IV and bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle

Detailed Description:

Patients will be treated with pemetrexed 500 mg/m2 IV and Bevacizumab 15 mg/kg IV every 3 weeks.The patient is treated indefinitely until side effects are deemed severe by the investigator or until progression. Disease progression is measured every 6 weeks using RECIST criteria.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recurrent epithelial ovarian or primary peritoneal carcinoma
Measurable disease
At lease 1 target lesion to assess response by RECIST
GOG performance status 0 or 1
Recovery from effects of recent surgery, radiotherapy or chemotherapy, must discontinue hormonal therapy
Must have had 1 prior platinum based chemotherapeutic regimen for management of primary disease
Must have had 1 prior regimen containing a taxane compound

Exclusion Criteria:

Prior therapy with pemetrexed or bevacizumab
Serious, non-healing wound, ulcer or bone fracture
Clinically significant cardiovascular disease
Active bleeding or pathogenic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major - vessels
Ascites or other third space fluid which cannot be controlled by drainage
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 or anticipation of need for major surgical procedure during course of study
History or evidence upon physical exam of CNS disease, including primary brain tumor, brain mets, seizure not controlled with standard medical therapy, history of CVA/stroke/TIA, or subarachnoid hemorrhage within 6 mos. of day 1
Proteinuria
History of abdominal fistula, GI perforation or intra-abdominal abscess within 6 mo.
Partial or complete small or large bowel obstruction within 3 mo.
Life expectancy less than 12 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868192

Contacts

Contact: Lynne Lippmann, CCRP	314-362-1760	lippmannl@wudosis.wustl.edu
Contact: Chrisann Winslow, RN, MSN	314-362-1794	winslowc@wudosis.wustl.edu

Locations

United States, Missouri
Washington University	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Lynne Lippmann, CCRP 314-362-1760 lippmannl@wudosis.wustl.edu
Contact: Chrisann Winslow, RN, BSN 314-362-1794 winslowc@wudosis.wustl.edu
Sub-Investigator: Janet S Rader, MD
Sub-Investigator: Thomas J Herzog, MD
Sub-Investigator: Matthew A Powell, MD
Sub-Investigator: Premal Thaker, MD
Sub-Investigator: Israel Zighelboim, MD
Sub-Investigator: Ashley Case, MD
Principal Investigator: David G Mutch, MD
United States, New York
Columbia University	Recruiting
New York City, New York, United States, 10027
Sub-Investigator: Tom Herzog, MD
Principal Investigator: Jason D Wright, MD

Sponsors and Collaborators

Washington University School of Medicine

Columbia University

Investigators

Principal Investigator:	David G Mutch, MD	Washington University School of Medicine
Principal Investigator:	Jason D Wright, MD	Columbia University

Responsible Party:	Washington University ( David Mutch, MD )
Study ID Numbers:	08-0508
Study First Received:	March 18, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00868192 History of Changes
Health Authority:	United States: Institutional Review Board