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

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ClinicalTrials.gov Identifier: NCT00408070
Recruitment Status : Terminated (Did not meet accrual goals.)
First Posted : December 6, 2006
Results First Posted : November 16, 2010
Last Update Posted : December 27, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Stage 3 Cancer Stage 4 Cancer Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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
Study Start Date : October 2006
Primary Completion Date : August 2009
Study Completion Date : October 2009


Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Response to Treatment (Clinical/Pathological) [ Time Frame: not assessed; study terminated early ]
  2. Rate of Decline of CA-125 [ Time Frame: not assessed; study terminated early ]
  3. To Determine the Degree and Type of Toxicity of This Combined Regimen [ Time Frame: weekly ]
  4. Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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: UConn Health
ClinicalTrials.gov Identifier: NCT00408070     History of Changes
Other Study ID Numbers: AVF 3696s
IRB 06-337-1
First Posted: December 6, 2006    Key Record Dates
Results First Posted: November 16, 2010
Last Update Posted: December 27, 2017
Last Verified: November 2017

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