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A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00669591
First received: April 28, 2008
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer

Condition Intervention Phase
Breast Cancer Drug: Bavituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer [ Time Frame: Up to six (6) 28-day cycles of docetaxel plus weekly bavituximab until disease progression. After chemotherapy, weekly bavituximab is continued until disease progression. Approximate duration 1 year. ]

Secondary Outcome Measures:
  • Secondary objectives include time to tumor progression, duration of response, overall survival, and safety. [ Time Frame: Approximately 1 year ]

Enrollment: 46
Study Start Date: January 2008
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients will receive up to six (6) 28-day cycles of docetaxel plus weekly bavituximab during the treatment phase. During the follow-up phase, patients will continue to receive weekly bavituximab until disease progression
Drug: Bavituximab
Weekly bavituximab infusion of 3 mg/kg combined with up to six 28-day cycles of docetaxel chemotherapy. After treatment phase, weekly bavituximab maintenance is continued until disease progression.

  Eligibility

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

Inclusion Criteria:

  • Adult females over age 18 with life expectancy of at least 3 months
  • Histologically or cytologically confirmed locally advanced or metastatic breast cancer
  • One and only one prior chemotherapy regimen (no prior docetaxel)
  • Measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral CT)
  • Adequate hematologic, renal, and hepatic function;

Exclusion Criteria:

  • Known history of bleeding diathesis or coagulopathy
  • Any current evidence of clinically significant bleeding
  • Any history of thromboembolic events
  • Concurrent hormone therapy
  • Prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy
  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: NCT00669591

Locations
Georgia
JSC. National Cancer Centre
Lisi Lake, Tbilisi, Georgia, 0177
Ltd. Oncological Center
Batumi, Georgia, 6000
Ltd. Chemotherapy and Immunotherapy clinic Medulla 6, Jikia Str
Tbilisi, Georgia, 0176
Ltd. Tbilisi Oncological Dispensary
Tblisi, Georgia, 0171
Sponsors and Collaborators
Peregrine Pharmaceuticals
  More Information

Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00669591     History of Changes
Other Study ID Numbers: PPHM 0704
Study First Received: April 28, 2008
Last Updated: April 19, 2017

Keywords provided by Peregrine Pharmaceuticals:
breast cancer
docetaxel chemotherapy
bavituximab
monoclonal antibody

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Antibodies, Monoclonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017