Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00669565
First received: April 28, 2008
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Carcinoma Breast Stage IV
Drug: Bavituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • The primary objective of this study is to determine the overall response rate (CR+PR) [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: July 2008
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00669565

Locations
India
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
  More Information

No publications provided

Responsible Party: A.J. Leyco, RN/Associate Director, Clinical Affairs, Peregrine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00669565     History of Changes
Other Study ID Numbers: PPHM 0702
Study First Received: April 28, 2008
Last Updated: March 23, 2011
Health Authority: India: Drugs Controller General of India

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014