Clinical trial NCT01160601: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Keywords: NSCLC
lung cancer
non small cell lung cancer
bavituximab
monoclonal antibody
Lead sponsor: Peregrine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: Until disease progression
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Jonesboro
country: United States
facility: Baptist Clinical Research
state: Arkansas
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Waterloo
country: United States
facility: Cedar Valley Medical Specialists, PC
state: Iowa
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center Research
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Knoxville
country: United States
facility: Hematology-Oncology of Knoxville/Mercy Medical Center
state: Tennessee
city: Portsmouth
country: United States
facility: Delta Hematology Oncology Associates, PC
state: Virginia
city: Tbilisi
country: Georgia
facility: JSC A.Gvamichava National Oncology Center
city: Tbilisi
country: Georgia
facility: Medulla Chemotherapy and Immunotherapy Clinic
city: Hyderabad
country: India
facility: BiBi General Hospital & Cancer Centre
state: Andhra Pradesh
city: Patna
country: India
facility: Mahavir Cancer Sansthan
state: Bihar
city: Hisar
country: India
facility: O.P. Jindal Institute of Cancer & Research
state: Haryana
city: Bangalore
country: India
facility: Bangalore Institute of Oncology Specialty Centre
state: Karnataka
city: Aurangabad
country: India
facility: Kodlikeri Memorial Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Cancer Care Clinic
state: Maharashtra
city: Nashik
country: India
facility: Shatabdi Superspecialty Hospital
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Jaipur
country: India
facility: SMS Medical College Hospital
state: Rajasthan
city: Pyatigorsk
country: Russian Federation
facility: State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
state: Stavropol Territory
city: Yaroslavl
country: Russian Federation
facility: State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
state: Yaroslavl Region
city: Chelyabinsk
country: Russian Federation
facility: State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
city: Ivanovo
country: Russian Federation
facility: State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
city: Moscow
country: Russian Federation
facility: Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
city: Saint-Petersburg
country: Russian Federation
facility: 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: Tula
country: Russian Federation
facility: State Institution of Healthcare "Tula Regional Oncology Dispensary"
city: Dnipropetrovsk
country: Ukraine
facility: City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
city: Donetsk
country: Ukraine
facility: Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy department #1
city: Kharkiv
country: Ukraine
facility: State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
city: Kyiv
country: Ukraine
facility: Kyiv City Oncology Hospital, Thoracal Department
city: Uzhgorod
country: Ukraine
facility: Uzhgorod Central City Clinical Hospital, City Oncology Center
Study officials:
References: