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

Sponsor:	Washington University School of Medicine
Collaborator:	Columbia University
Information provided by (Responsible Party):	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00868192

Sponsor:

Washington University School of Medicine

Collaborator:

Columbia University

Information provided by (Responsible Party):

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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

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 Study Completion Date:	March 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pemetrexed and bevacizumab	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

United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University
New York City, New York, United States, 10027

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

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00868192 History of Changes
Other Study ID Numbers:	08-0508 / 201102272
Study First Received:	March 18, 2009
Last Updated:	November 9, 2011
Health Authority:	United States: Institutional Review Board