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

This study has been completed.
Sponsor:
Information provided by:
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00669591
First received: April 28, 2008
Last updated: August 26, 2010
Last verified: August 2010
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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. ] [ Designated as safety issue: No ]

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

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
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669591

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

No publications provided

Responsible Party: A.J. Leyco, RN/Associate Director, Clinical Affairs, Peregrine
ClinicalTrials.gov Identifier: NCT00669591     History of Changes
Other Study ID Numbers: PPHM 0704
Study First Received: April 28, 2008
Last Updated: August 26, 2010
Health Authority: Georgia: Ministry of Health

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
Antibodies, Monoclonal
Docetaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014