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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:
Collaborator:
Genentech, Inc.
Information provided by:
UConn Health
ClinicalTrials.gov Identifier:
NCT00408070
First received: December 5, 2006
Last updated: November 16, 2010
Last verified: November 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Rate of Decline of CA-125 [ Time Frame: not assessed; study terminated early ] [ Designated as safety issue: No ]
  • To Determine the Degree and Type of Toxicity of This Combined Regimen [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders 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
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: 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 
Study First Received: December 5, 2006
Results First Received: October 14, 2010
Last Updated: November 16, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016