Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00868192
First received: March 18, 2009
Last updated: July 12, 2013
Last verified: July 2013
  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
Drug: Bevacizumab
Phase 2

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 and Primary Peritoneal Carcinoma

Resource links provided by NLM:


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 ]

Enrollment: 38
Study Start Date: May 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed and bevacizumab

Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle

Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle

Drug: Pemetrexed
Other Name: Alimta
Drug: Bevacizumab
Other Name: Avastin

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University
New York City, New York, United States, 10027
Sponsors and Collaborators
Washington University School of Medicine
Columbia University
Investigators
Principal Investigator: David G Mutch, M.D. Washington University School of Medicine
  More Information

Additional Information:
Publications:

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: July 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bevacizumab
Pemetrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 22, 2014