Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian 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: NCT00511992
Recruitment Status : Completed
First Posted : August 6, 2007
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Genentech, Inc.
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Condition or disease Intervention/treatment Phase
Advanced Ovarian Carcinoma Primary Peritoneal Carcinoma Ovarian Carcinosarcoma Drug: Avastin Drug: Paclitaxel Drug: Cisplatin Phase 2

Detailed Description:

Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.

Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Paclitaxel (TAXOL), Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer
Study Start Date : July 2007
Actual Primary Completion Date : August 3, 2015
Actual Study Completion Date : August 3, 2015

Arm Intervention/treatment
Experimental: Avastin Drug: Avastin

Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)

Consolidation Treatment:

Avastin 15mg/kg IV every 21 days x 12 cycles

Other Name: Bevacizumab

Drug: Paclitaxel
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles

Drug: Cisplatin
75mg/m2 IP day 2 every 21 days x 6 cycles

Primary Outcome Measures :
  1. Number of Patients Able to Complete 6 Cycles of Treatment. [ Time Frame: 2 years ]
    Completion of cycle 6

Secondary Outcome Measures :
  1. Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin. [ Time Frame: 2 years ]
    CTCAE assessment of toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma.
  • Adequate bone marrow, renal, and hepatic function
  • Patients must be entered no more than twelve weeks postoperatively

Exclusion Criteria:

  • Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
  • Stage IV or suboptimally debulked disease following primary cytoreductive surgery
  • Patients who have received prior radiotherapy or chemotherapy.

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): NCT00511992

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Genentech, Inc.
Principal Investigator: D. Scott McMeekin, MD University of Oklahoma

Responsible Party: University of Oklahoma Identifier: NCT00511992     History of Changes
Other Study ID Numbers: 2674
First Posted: August 6, 2007    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by University of Oklahoma:
Ovarian Cancer
Gynecologic Cancer
Ovarian Carcinoma
Peritoneal Carcinoma
IP chemotherapy

Additional relevant MeSH terms:
Ovarian Neoplasms
Mixed Tumor, Mullerian
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Complex and Mixed
Neoplasms, Connective and Soft Tissue
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors