Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer - Full Text View

Purpose

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

Condition	Intervention	Phase
Non-small-cell Lung Cancer	Drug: Docetaxel plus bavituximab or placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:

Objective Response Rate [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Enrollment:	121
Study Start Date:	June 2010
Study Completion Date:	May 2013
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Docetaxel plus bavituximab 1 mg/kg	Drug: Docetaxel plus bavituximab or placebo Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
Experimental: Docetaxel plus bavituximab 3 mg/kg	Drug: Docetaxel plus bavituximab or placebo Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
Placebo Comparator: Docetaxel plus placebo	Drug: Docetaxel plus bavituximab or placebo Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults over age 18 years of age with a life expectancy of at least 3 months.
Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen.
Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Adequate hematologic, renal, and hepatic function.
PT/INR ≤ 1.5 × ULN; aPTT time ≤ 1.5 × ULN.
New York Heart Association classification I or II

Exclusion Criteria:

Squamous, small cell, or mixed histology.
Known history of bleeding diathesis or coagulopathy.
Cavitary tumors or tumors invading or abutting large blood vessels.
Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening.
Venous thromboembolic events within 6 months of screening.
Ongoing therapy with oral or parenteral anticoagulants.
Concurrent estrogens, anti-estrogens or progesterone compounds.
Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day 1.
Symptomatic or clinically active brain metastases.
Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening.
Grade 2 or higher peripheral neuropathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138163

Show 53 Study Locations

Sponsors and Collaborators

Peregrine Pharmaceuticals

More Information

No publications provided

Responsible Party:	Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01138163 History of Changes
Other Study ID Numbers:	PPHM 0902
Study First Received:	June 3, 2010
Last Updated:	May 3, 2013
Health Authority:	United States: Food and Drug Administration India: Drugs Controller General of India

Keywords provided by Peregrine Pharmaceuticals:

NSCLC
second-line
lung cancer

non small cell lung cancer
bavituximab
monoclonal antibody

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

Respiratory Tract Diseases
Docetaxel
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013