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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peregrine Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Bavituximab; Carboplatin; Paclitaxel

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