Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00511992
First received: August 3, 2007
Last updated: May 20, 2014
Last verified: May 2014
  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
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 II Study of Paclitaxel, Intraperitoneal Cisplatin and IV Bevacizumab Followed by Bevacizumab Consolidation for Advanced Ovarian and Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Evaluating the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin Drug: Avastin

Initial Treatment:

Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, 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 Names:
  • Avastin
  • Bevacizumab

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
Genders 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
Investigators
Principal Investigator: D. Scott McMeekin, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00511992     History of Changes
Other Study ID Numbers: AVF3953 McMeekin
Study First Received: August 3, 2007
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Carcinoma
Carcinosarcoma
Mixed Tumor, Mullerian
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014