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

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. Identifier: NCT00408070
Recruitment Status : Terminated (Did not meet accrual goals.)
First Posted : December 6, 2006
Results First Posted : November 16, 2010
Last Update Posted : March 8, 2018
Genentech, Inc.
Information provided by (Responsible Party):
UConn Health

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

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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
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

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)

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: 12 months ]
  2. Rate of Decline of CA-125 [ Time Frame: 12 months ]
  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 ]

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.

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

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

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 identifier (NCT number): NCT00408070

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

Additional Information:
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Responsible Party: UConn Health 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: March 8, 2018
Last Verified: February 2018
Keywords provided by UConn Health:
ovarian cancer
fallopian tube cancer
peritoneal cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
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
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors