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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-small-cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01138163

Run by

Peregrine Pharmaceuticals

People needed

121

Starts

2010-06-01

Expected to finish

2013-05-01

Last updated by the study team

2017-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• South Bay Hematology Oncology — Campbell, California, United States
• Medical Oncology Care Associates — Orange, California, United States
• American Institute of Research — Whittier, California, United States
• The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc — Boca Raton, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Georgia Cancer Specialists, PC — Atlanta, Georgia, United States
• Northwest Georgia Oncology Centers, PC — Marietta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Cedar Valley Medical Specialists, PC — Waterloo, Iowa, United States
• Jewish Hospital — Louisville, Kentucky, United States
• Frederick Memorial Hospital Regional Cancer Therapy Center — Frederick, Maryland, United States
• Nebraska Hematology Oncology, PC — Lincoln, Nebraska, United States
• Hanover Medical Specialists, PA — Wilmington, North Carolina, United States
• The Christ Hospital Cancer Center Research — Cincinnati, Ohio, United States
• Oncology/ Hematology Care, Inc — Cincinnati, Ohio, United States
• Dayton Clinical Oncology Program — Dayton, Ohio, United States
• Pennsylvania State Hershey Cancer Institute — Hershey, Pennsylvania, United States
• South Carolina Oncology Associates — Columbia, South Carolina, United States
• Sarah Cannon Research Institute, LLC — Nashville, Tennessee, United States
• Coastal Bend Cancer Center — Corpus Christi, Texas, United States
• Mary Crowley Cancer Research Centers — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Utah Hospitals and Clinics, Huntsman Cancer Institute — Salt Lake City, Utah, United States
• JSC A.Gvamichava National Oncology Center — Tbilisi, Georgia
• Ironwood Cancer and Research Center — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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