Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
NCT ID: NCT01160601
Last Updated: 2017-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2010-06-30
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
NCT00687817
Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
NCT01138163
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
NCT01323062
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
NCT00723957
Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC
NCT00313768
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
paclitaxel/carboplatin plus bavituximab
Patients 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
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.
bavituximab
Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.
paclitaxel/carboplatin
Patients 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.
Paclitaxel / Carboplatin
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paclitaxel / Carboplatin
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.
bavituximab
Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peregrine Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ironwood Cancer and Research Center
Chandler, Arizona, United States
Baptist Clinical Research
Jonesboro, Arkansas, United States
American Institute of Research
Whittier, California, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Community Hospital
Munster, Indiana, United States
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Hematology-Oncology of Knoxville/Mercy Medical Center
Knoxville, Tennessee, United States
Delta Hematology Oncology Associates, PC
Portsmouth, Virginia, 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, India
Mahavir Cancer Sansthan
Patna, Bihar, India
O.P. Jindal Institute of Cancer & Research
Hisar, Haryana, India
Bangalore Institute of Oncology Specialty Centre
Bangalore, Karnataka, India
Kodlikeri Memorial Hospital
Aurangabad, Maharashtra, India
Cancer Care Clinic
Nagpur, Maharashtra, India
Shatabdi Superspecialty Hospital
Nashik, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
SMS Medical College Hospital
Jaipur, Rajasthan, India
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
Pyatigorsk, Stavropol Territory, Russia
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, Yaroslavl Oblast, Russia
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
Chelyabinsk, , Russia
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
Ivanovo, , Russia
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
Moscow, , 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, , Russia
State Institution of Healthcare "Tula Regional Oncology Dispensary"
Tula, , Russia
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
Dnipropetrovsk, , Ukraine
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy department #1
Donetsk, , Ukraine
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
Kharkiv, , Ukraine
Kyiv City Oncology Hospital, Thoracal Department
Kyiv, , Ukraine
Uzhgorod Central City Clinical Hospital, City Oncology Center
Uzhhorod, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PPHM 1001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.