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

NCT00669565 | Completed Phase 2

• 1 other identifier: PPHM 0702
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 9

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.

Conditions

Carcinoma Breast Stage IV

Keywords

Locally Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to determine the overall response rate (CR+PR)

  Until disease progression

Interventions

Bavituximab DRUG

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (9)

Rajalakshmi Multispecialty Hospital

Bangalore, India

Location

Bangalore Institute of Oncology

Banglore, India

Location

Apollo Specialty Hospitals

Chennai, India

Location

Nizam's Institute of Medical Sciences

Hyderabaad, India

Location

Regional Cancer Center

Kerala, India

Location

Medical College Hospital

Kolkata, India

Location

Bharath Hospital and Institite of Oncology

Mysore, India

Location

Curie Manavata Cancer Center

Nashik, India

Location

Ruby Hall Clinic

Pune, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

bavituximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 24, 2011

Record last verified: 2011-03

Locations

IN (9)