Back to resultsStudy of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Paclitaxel / Carboplatin
bavituximab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer focused on measuring NSCLC, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody
Eligibility 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.
Sites / Locations
- Ironwood Cancer and Research Center
- Baptist Clinical Research
- American Institute of Research
- Baptist Cancer Institute
- Community Hospital
- Cedar Valley Medical Specialists, PC
- Southeast Nebraska Cancer Center
- Dartmouth Hitchcock Medical Center
- The Center for Cancer and Hematologic Disease
- San Juan Oncology Associates
- Presbyterian Hospital
- Gabrail Cancer Center
- The Christ Hospital Cancer Center Research
- Signal Point Clinical Research Center, LLC
- Gettysburg Cancer Center
- Hematology-Oncology of Knoxville/Mercy Medical Center
- Delta Hematology Oncology Associates, PC
- JSC A.Gvamichava National Oncology Center
- Medulla Chemotherapy and Immunotherapy Clinic
- BiBi General Hospital & Cancer Centre
- Mahavir Cancer Sansthan
- O.P. Jindal Institute of Cancer & Research
- Bangalore Institute of Oncology Specialty Centre
- Kodlikeri Memorial Hospital
- Cancer Care Clinic
- Shatabdi Superspecialty Hospital
- Ruby Hall Clinic
- SMS Medical College Hospital
- State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
- State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
- State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
- State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
- Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
- 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"
- State Institution of Healthcare "Tula Regional Oncology Dispensary"
- City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
- Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy department #1
- State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
- Kyiv City Oncology Hospital, Thoracal Department
- Uzhgorod Central City Clinical Hospital, City Oncology Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
paclitaxel/carboplatin plus bavituximab
paclitaxel/carboplatin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Objective Response Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01160601
Brief Title
Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peregrine Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
Keywords
NSCLC, lung cancer, non small cell lung cancer, bavituximab, monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paclitaxel/carboplatin plus bavituximab
Arm Type
Experimental
Arm Description
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.
Arm Title
paclitaxel/carboplatin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel / Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
bavituximab
Intervention Description
Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.
Primary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
Until disease progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ironwood Cancer and Research Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Baptist Clinical Research
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Cedar Valley Medical Specialists, PC
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50701
Country
United States
Facility Name
Southeast Nebraska Cancer Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
The Center for Cancer and Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The Christ Hospital Cancer Center Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Hematology-Oncology of Knoxville/Mercy Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Delta Hematology Oncology Associates, PC
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23704
Country
United States
Facility Name
JSC A.Gvamichava National Oncology Center
City
Tbilisi
Country
Georgia
Facility Name
Medulla Chemotherapy and Immunotherapy Clinic
City
Tbilisi
Country
Georgia
Facility Name
BiBi General Hospital & Cancer Centre
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500024
Country
India
Facility Name
Mahavir Cancer Sansthan
City
Patna
State/Province
Bihar
ZIP/Postal Code
801505
Country
India
Facility Name
O.P. Jindal Institute of Cancer & Research
City
Hisar
State/Province
Haryana
ZIP/Postal Code
125005
Country
India
Facility Name
Bangalore Institute of Oncology Specialty Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Facility Name
Kodlikeri Memorial Hospital
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431 005
Country
India
Facility Name
Cancer Care Clinic
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Shatabdi Superspecialty Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 005
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
SMS Medical College Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
City
Pyatigorsk
State/Province
Stavropol Territory
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
City
Yaroslavl
State/Province
Yaroslavl Region
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
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"
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State Institution of Healthcare "Tula Regional Oncology Dispensary"
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy department #1
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Kyiv City Oncology Hospital, Thoracal Department
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Uzhgorod Central City Clinical Hospital, City Oncology Center
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
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