Clinical trial NCT00669565: Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma Breast Stage IV
Keywords: Locally Advanced or Metastatic Breast Cancer
Lead sponsor: Peregrine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-30
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The primary objective of this study is to determine the overall response rate (CR+PR)
timeFrame: Until disease progression
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Rajalakshmi Multispecialty Hospital
city: Banglore
country: India
facility: Bangalore Institute of Oncology
city: Chennai
country: India
facility: Apollo Specialty Hospitals
city: Hyderabaad
country: India
facility: Nizam's Institute of Medical Sciences
city: Kerala
country: India
facility: Regional Cancer Center
city: Kolkata
country: India
facility: Medical College Hospital
city: Mysore
country: India
facility: Bharath Hospital and Institite of Oncology
city: Nashik
country: India
facility: Curie Manavata Cancer Center
city: Pune
country: India
facility: Ruby Hall Clinic
Study officials:
References: