Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast 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: NCT00669565
Recruitment Status : Completed
First Posted : April 30, 2008
Last Update Posted : March 24, 2011
Information provided by:
Peregrine Pharmaceuticals

Brief Summary:
This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Carcinoma Breast Stage IV Drug: Bavituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer
Study Start Date : July 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Drug: Bavituximab
    Receive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles.

Primary Outcome Measures :
  1. The primary objective of this study is to determine the overall response rate (CR+PR) [ Time Frame: Until disease progression ]

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:

  • Living in India for the duration of the study
  • Adult females over age 18 years of age with a life expectancy of at least 3 months
  • Confirmed breast cancer with evidence of locally advanced or metastatic disease
  • Disease that is measurable by radiology imaging
  • Ambulatory and capable of all selfcare but unable to carry out any work activities.
  • Adequate laboratory results (hematologic, renal, hepatic)
  • Negative pregnancy test

Exclusion Criteria:

  • History of or susceptibility to bleeding or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
  • Any history of thromboembolic events (clots within blood vessels)
  • Ongoing treatment with high doses of anticoagulants
  • Use of hormone therapy
  • Advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
  • Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
  • Radiotherapy within 2 weeks entering the study
  • Chemotherapy, immunotherapy or radiotherapy within 4 weeks of starting the study
  • Allergies to Polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine)
  • Diagnosed and active CNS disease or metastatic lesions
  • Major surgery within 4 weeks of starting the study
  • Pregnant or nursing
  • Uncontrolled disease (e.g., diabetes, hypertension, thyroid disease)
  • History of heart disease
  • History of any condition requiring treatment with anti-inflammatory, anti-platelet drugs or steroids
  • Diagnosed with HIV or hepatitis

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): NCT00669565

Rajalakshmi Multispecialty Hospital
Bangalore, India
Bangalore Institute of Oncology
Banglore, India
Apollo Specialty Hospitals
Chennai, India
Nizam's Institute of Medical Sciences
Hyderabaad, India
Regional Cancer Center
Kerala, India
Medical College Hospital
Kolkata, India
Bharath Hospital and Institite of Oncology
Mysore, India
Curie Manavata Cancer Center
Nashik, India
Ruby Hall Clinic
Pune, India
Sponsors and Collaborators
Peregrine Pharmaceuticals

Responsible Party: A.J. Leyco, RN/Associate Director, Clinical Affairs, Peregrine Pharmaceuticals Inc. Identifier: NCT00669565     History of Changes
Other Study ID Numbers: PPHM 0702
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: March 2011

Keywords provided by Peregrine Pharmaceuticals:
Locally Advanced or Metastatic Breast Cancer

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