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


Phase 2
18 Years
N/A
Not Enrolling
Female
Carcinoma Breast Stage IV

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Until disease progression

Safety Issue:

No

Authority:

India: Drugs Controller General of India

Study ID:

PPHM 0702

NCT ID:

NCT00669565

Start Date:

July 2008

Completion Date:

August 2010

Related Keywords:

  • Carcinoma Breast Stage IV
  • Locally Advanced or Metastatic Breast Cancer
  • Breast Neoplasms
  • Carcinoma

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