Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
1 other identifier
interventional
86
5 countries
40
Brief Summary
This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2010
Typical duration for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 8, 2010
CompletedFirst Posted
Study publicly available on registry
July 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedApril 19, 2017
April 1, 2017
3 years
July 8, 2010
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
Until disease progression
Study Arms (2)
paclitaxel/carboplatin plus bavituximab
EXPERIMENTALPatients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly.
paclitaxel/carboplatin
ACTIVE COMPARATORPatients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
Interventions
Patients will receive commercially available paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.
Eligibility Criteria
You may qualify if:
- Adults over 18 years of age with a life expectancy of at least 3 months.
- Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
- Adequate hematologic, renal and hepatic function.
- PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.
You may not qualify if:
- Squamous cell, small cell, or mixed histology.
- Known history of bleeding diathesis or coagulopathy.
- Cavitary tumors or tumors abutting large blood vessels.
- Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
- Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening.
- Ongoing therapy with oral or parenteral anticoagulants.
- Concurrent estrogens, anti-estrogens or progesterone compounds.
- Grade 2 or higher peripheral neuropathy.
- Radiotherapy within 2 weeks preceding Study Day 1.
- Symptomatic or clinically active brain metastases.
- Major surgery within 4 weeks of Study Day 1.
- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).
- Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Ironwood Cancer and Research Center
Chandler, Arizona, 85224, United States
Baptist Clinical Research
Jonesboro, Arkansas, 72401, United States
American Institute of Research
Whittier, California, 90603, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Community Hospital
Munster, Indiana, 46321, United States
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, 50701, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, 45219, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Hematology-Oncology of Knoxville/Mercy Medical Center
Knoxville, Tennessee, 37909, United States
Delta Hematology Oncology Associates, PC
Portsmouth, Virginia, 23704, United States
JSC A.Gvamichava National Oncology Center
Tbilisi, Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia
BiBi General Hospital & Cancer Centre
Hyderabad, Andhra Pradesh, 500024, India
Mahavir Cancer Sansthan
Patna, Bihar, 801505, India
O.P. Jindal Institute of Cancer & Research
Hisar, Haryana, 125005, India
Bangalore Institute of Oncology Specialty Centre
Bangalore, Karnataka, 560027, India
Kodlikeri Memorial Hospital
Aurangabad, Maharashtra, 431 005, India
Cancer Care Clinic
Nagpur, Maharashtra, 440012, India
Shatabdi Superspecialty Hospital
Nashik, Maharashtra, 422 005, India
Ruby Hall Clinic
Pune, Maharashtra, 411 001, India
SMS Medical College Hospital
Jaipur, Rajasthan, 302004, India
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
Pyatigorsk, Stavropol Territory, 357502, Russia
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, Yaroslavl Oblast, 150054, Russia
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
Chelyabinsk, 454087, Russia
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
Ivanovo, 153013, Russia
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
Moscow, 115478, Russia
State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University named after academician I.P. Pavlov of Federal Agency of Healthcare and Social Development"
Saint Petersburg, 197022, Russia
State Institution of Healthcare "Tula Regional Oncology Dispensary"
Tula, 300053, Russia
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
Dnipropetrovsk, 49102, Ukraine
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy department #1
Donetsk, 83092, Ukraine
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
Kharkiv, 61024, Ukraine
Kyiv City Oncology Hospital, Thoracal Department
Kyiv, 03115, Ukraine
Uzhgorod Central City Clinical Hospital, City Oncology Center
Uzhhorod, 88000, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2010
First Posted
July 12, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2013
Study Completion
September 1, 2013
Last Updated
April 19, 2017
Record last verified: 2017-04