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

April 18, 2017 updated by: Peregrine Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: Until disease progression
Until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peregrine Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (ESTIMATE)

July 12, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPHM 1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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