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Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00511992
First received: August 3, 2007
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Advanced Ovarian Carcinoma Primary Peritoneal Carcinoma Ovarian Carcinosarcoma Drug: Avastin Drug: Paclitaxel Drug: Cisplatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

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


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


Enrollment: 20
Study Start Date: July 2007
Study Completion Date: August 3, 2015
Primary Completion Date: August 3, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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.
  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: NCT00511992

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

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00511992     History of Changes
Other Study ID Numbers: 2674
Study First Received: August 3, 2007
Results First Received: April 14, 2017
Last Updated: June 2, 2017

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

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Carcinosarcoma
Mixed Tumor, Mullerian
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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
Sarcoma
Neoplasms, Connective and Soft Tissue
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on August 23, 2017