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Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01160601
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Paclitaxel / Carboplatin Drug: bavituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Drug: bavituximab
Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.

Active Comparator: 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.
Drug: 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.




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Until disease progression ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160601


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Locations
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United States, Arizona
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
United States, Arkansas
Baptist Clinical Research
Jonesboro, Arkansas, United States, 72401
United States, California
American Institute of Research
Whittier, California, United States, 90603
United States, Florida
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
United States, Indiana
Community Hospital
Munster, Indiana, United States, 46321
United States, Iowa
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, United States, 50701
United States, Nebraska
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
United States, New Mexico
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, United States, 45219
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
United States, Pennsylvania
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States, 17325
United States, Tennessee
Hematology-Oncology of Knoxville/Mercy Medical Center
Knoxville, Tennessee, United States, 37909
United States, Virginia
Delta Hematology Oncology Associates, PC
Portsmouth, Virginia, United States, 23704
Georgia
JSC A.Gvamichava National Oncology Center
Tbilisi, Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia
India
BiBi General Hospital & Cancer Centre
Hyderabad, Andhra Pradesh, India, 500024
Mahavir Cancer Sansthan
Patna, Bihar, India, 801505
O.P. Jindal Institute of Cancer & Research
Hisar, Haryana, India, 125005
Bangalore Institute of Oncology Specialty Centre
Bangalore, Karnataka, India, 560027
Kodlikeri Memorial Hospital
Aurangabad, Maharashtra, India, 431 005
Cancer Care Clinic
Nagpur, Maharashtra, India, 440012
Shatabdi Superspecialty Hospital
Nashik, Maharashtra, India, 422 005
Ruby Hall Clinic
Pune, Maharashtra, India, 411 001
SMS Medical College Hospital
Jaipur, Rajasthan, India, 302004
Russian Federation
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
Pyatigorsk, Stavropol Territory, Russian Federation, 357502
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, Yaroslavl Region, Russian Federation, 150054
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
Chelyabinsk, Russian Federation, 454087
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
Ivanovo, Russian Federation, 153013
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
Moscow, Russian Federation, 115478
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, Russian Federation, 197022
State Institution of Healthcare "Tula Regional Oncology Dispensary"
Tula, Russian Federation, 300053
Ukraine
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
Dnipropetrovsk, Ukraine, 49102
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy department #1
Donetsk, Ukraine, 83092
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
Kharkiv, Ukraine, 61024
Kyiv City Oncology Hospital, Thoracal Department
Kyiv, Ukraine, 03115
Uzhgorod Central City Clinical Hospital, City Oncology Center
Uzhgorod, Ukraine, 88000
Sponsors and Collaborators
Peregrine Pharmaceuticals

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Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01160601     History of Changes
Other Study ID Numbers: PPHM 1001
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Keywords provided by Peregrine Pharmaceuticals:
NSCLC
lung cancer
non small cell lung cancer
bavituximab
monoclonal antibody
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Bavituximab
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs