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

Carcinoma Breast Stage IV Clinical Trial

Official title:

A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669565
• Other study ID #: PPHM 0702
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2008
• Last updated: March 23, 2011
• Start date: July 2008
• Est. completion date: August 2010

Study information

• Verified date: March 2011
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma Breast Stage IV

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to determine the overall response rate (CR+PR)		Until disease progression	No