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Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer

This study has been terminated.
(Did not meet accrual goals.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408070
First Posted: December 6, 2006
Last Update Posted: November 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by:
UConn Health
  Purpose
The primary objective is to determine whether the addition of bevacizumab to a regimen of carboplatin plus paclitaxel significantly improves Progression Free Survival (PFS) for patient with Stage III suboptimally cytoreduced or Stage IV ovarian, primary peritoneal or fallopian tube carcinomas.

Condition Intervention Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Stage 3 Cancer Stage 4 Cancer Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by UConn Health:

Primary Outcome Measures:
  • Progression Free Survival Rate at 9 Months [ Time Frame: 9 months ]
    This Outcome is measuring the number of particpants who have survived.


Secondary Outcome Measures:
  • Response to Treatment (Clinical/Pathological) [ Time Frame: not assessed; study terminated early ]
  • Rate of Decline of CA-125 [ Time Frame: not assessed; study terminated early ]
  • To Determine the Degree and Type of Toxicity of This Combined Regimen [ Time Frame: weekly ]
  • Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy [ Time Frame: 12 months ]

Enrollment: 5
Study Start Date: October 2006
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.
Drug: Bevacizumab
cycle 2 (6 cycles re-evaluated and follow up)
Other Name: Avastin (brand name)
Drug: Carboplatin
cycle #1 and continuous through entire regimen; treated every 3 weeks
Other Name: Paraplatin
Drug: Paclitaxel
cycle #1 and continuous through entire regimen; treated every 3 weeks
Other Name: Taxol (brand name)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of primary peritoneal carcinoma, fallopian tube epithelial ovarian carcinoma,
  • stage III suboptimal surgery or biopsy,
  • stage IV disease
  • no prior chemotherapy

Exclusion Criteria:

  • unstable heart conditions
  • high blood pressure
  • vascular disorders
  • bleeding problems
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408070


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Genentech, Inc.
Investigators
Principal Investigator: Carolyn Runowicz, MD UConn Health
  More Information

Additional Information:
Responsible Party: Carolyn Runowicz, MD, Univ. of CT Health Center
ClinicalTrials.gov Identifier: NCT00408070     History of Changes
Other Study ID Numbers: AVF 3696s
IRB 06-337-1
First Submitted: December 5, 2006
First Posted: December 6, 2006
Results First Submitted: October 14, 2010
Results First Posted: November 16, 2010
Last Update Posted: November 24, 2010
Last Verified: November 2010

Keywords provided by UConn Health:
ovarian cancer
fallopian tube cancer
peritoneal cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal 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
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents