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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160601
• Other study ID #: PPHM 1001
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2010
• Last updated: April 18, 2017
• Start date: June 2010
• Est. completion date: September 2013

Study information

• Verified date: April 2017
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Georgia	JSC A.Gvamichava National Oncology Center	Tbilisi
Georgia	Medulla Chemotherapy and Immunotherapy Clinic	Tbilisi
India	Kodlikeri Memorial Hospital	Aurangabad	Maharashtra
India	Bangalore Institute of Oncology Specialty Centre	Bangalore	Karnataka
India	O.P. Jindal Institute of Cancer & Research	Hisar	Haryana
India	BiBi General Hospital & Cancer Centre	Hyderabad	Andhra Pradesh
India	SMS Medical College Hospital	Jaipur	Rajasthan
India	Cancer Care Clinic	Nagpur	Maharashtra
India	Shatabdi Superspecialty Hospital	Nashik	Maharashtra
India	Mahavir Cancer Sansthan	Patna	Bihar
India	Ruby Hall Clinic	Pune	Maharashtra
Russian Federation	State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"	Chelyabinsk
Russian Federation	State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "	Ivanovo
Russian Federation	Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"	Moscow
Russian Federation	State Institution of Healthcare "Pyatigorsk Oncology Dispensary"	Pyatigorsk	Stavropol Territory
Russian Federation	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	State Institution of Healthcare "Tula Regional Oncology Dispensary"	Tula
Russian Federation	State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"	Yaroslavl	Yaroslavl Region
Ukraine	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	Uzhgorod
United States	Gabrail Cancer Center	Canton	Ohio
United States	Ironwood Cancer and Research Center	Chandler	Arizona
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	The Center for Cancer and Hematologic Disease	Cherry Hill	New Jersey
United States	The Christ Hospital Cancer Center Research	Cincinnati	Ohio
United States	San Juan Oncology Associates	Farmington	New Mexico
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Baptist Clinical Research	Jonesboro	Arkansas
United States	Hematology-Oncology of Knoxville/Mercy Medical Center	Knoxville	Tennessee
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	Signal Point Clinical Research Center, LLC	Middletown	Ohio
United States	Community Hospital	Munster	Indiana
United States	Delta Hematology Oncology Associates, PC	Portsmouth	Virginia
United States	Cedar Valley Medical Specialists, PC	Waterloo	Iowa
United States	American Institute of Research	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Countries where clinical trial is conducted

United States,  Georgia,  India,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		Until disease progression