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Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Terminated
CT.gov ID
NCT00850577
Collaborator
(none)
255
Enrollment
55
Locations
2
Arms
50
Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
255 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Paclitaxel/Carboplatin/CT-322

Drug: Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Other Names:
  • Taxol

    • Drug: Carboplatin
    Solution, IV, AUC=6, Q21days, 6 cycles
    Other Names:
  • Paraplatin

    • Drug: CT-322
    Solution, IV, 2 mg/kg, Q7days, Until PD
    Other Names:
  • BMS-844203

    		•
    Active Comparator: Paclitaxel/Carboplatin/Bevacizumab/Placebo

    Drug: Paclitaxel
    Solution, IV, 200 mg/m2, Q21days, 6 cycles
    Other Names:
  • Taxol

    • Drug: Carboplatin
    Solution, IV, AUC=6, Q21days, 6 cycles
    Other Names:
  • Paraplatin

    • Drug: Bevacizumab
    Solution, IV, 15 mg/kg, Q21days, Until PD
    Other Names:
  • Avastin

    • Drug: Bevacizumab placebo (ie saline solution)
    Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
    Other Names:
  • Saline solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival based on tumor assessments (CT scans/MRI) [every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC]

    Secondary Outcome Measures

    1. Overall survival (OS) between 2 arms [every 12 weeks]

    2. Objective tumor response rate (ORR) between 2 arms [every 6 weeks]

    3. Safety in the CT-322 plus carboplatin and paclitaxel arm [weekly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

    Inclusion Criteria:

    • ECOG Performance Status (PS) <=1

    • Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC

    • Measurable disease by RECIST guidelines

    Exclusion Criteria:

    • Evidence of predominantly squamous-cell histology

    • Known CNS metastases

    • Any prior antineoplastic systemic regimens for NSCLC

    • Excessive risk of bleeding (including use of therapeutic anticoagulation) and history of thrombotic or embolic cerebrovascular accident

    • Gross hemoptysis (≥1/2 tsp of red blood)

    • Uncontrolled hypertension

    • Clinically significant cardiovascular disease

    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

    • Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Acrc/Arizona Clinical Research Center, Inc. Tucson Arizona United States 85715
    2 Sharp Clinical Oncology Research San Diego California United States 92123
    3 Cancer Institute Of Florida Orlando Florida United States 32804
    4 Palm Beach Cancer Institute West Palm Beach Florida United States 33401
    5 Clintell, Inc. Skokie Illinois United States 60077
    6 Cancer Center Of Kansas Wichita Kansas United States 67214
    7 Kentucky Cancer Clinic Hazard Kentucky United States 41701
    8 Annapolis Oncology Center Annapolis Maryland United States 21401
    9 Meritus Center For Clinical Research Hagerstown Maryland United States 21740
    10 North Mississippi Hematology And Oncology Associates, Ltd Tupelo Mississippi United States 38801
    11 Piedmont Hematology Oncology Associates, Pllc Winston-salem North Carolina United States 27103
    12 North Canton Medical Clinic Center Canton Ohio United States 44710
    13 Kaiser Permanente Oncology/Hematology Portland Oregon United States 97227
    14 Guthrie Clinic, Ltd Sayre Pennsylvania United States 18840
    15 Rhode Island Hospital Providence Rhode Island United States 02903
    16 Charleston Hematology Oncology Associates, Pa Charleston South Carolina United States 29414
    17 Cancer Center At Cookeville Regional Medical Center Cookeville Tennessee United States 38501
    18 University Of Tennessee Cancer Institute Memphis Tennessee United States 38104
    19 Blue Ridge Cancer Care Christiansburg Virginia United States 24073
    20 Providence Western Washington Oncology Lacey Washington United States 98503
    21 Local Institution Fortaleza Ceara Brazil 60336550
    22 Local Institution Belo Horizonte Minas Gerais Brazil 30130-100
    23 Local Institution Porto Alegre Rio Grande Do Sul Brazil 90050-170
    24 Local Institution Barretos Sao Paulo Brazil 14784-400
    25 Local Institution Rio De Janeiro Brazil 20231-050
    26 Local Institution Sao Paulo Brazil 04024-002
    27 Local Institution Sao Paulo Brazil 05403-000
    28 Local Institution Marseille Cedex 20 France 13915
    29 Local Institution Paris France 75005
    30 Local Institution Rennes Cedex 9 France 35033
    31 Local Institution Toulouse Cedex 9 France 31059
    32 Local Institution Tours Cedex France 37044
    33 Local Institution Meldola (Fc) Italy 47014
    34 Local Institution Ravenna Italy 48100
    35 Local Institution Rimini Italy 47900
    36 Local Institution Roma Italy 00189
    37 Local Institution Terni Italy 05100
    38 Local Institution Bialystok Poland 15-540
    39 Local Institution Gdansk Poland 80952
    40 Local Institution Otwock Poland 05-400
    41 Local Institution Poznan Poland 60 569
    42 Local Institution Szczecin Poland 70-891
    43 Local Institution Warsaw Poland 02-781
    44 Local Institution Chelyabinsk Russian Federation 454087
    45 Local institution Ivanovo Russian Federation 153013
    46 Local Institution Moscow Russian Federation 115 478
    47 Local Institution Moscow Russian Federation 115478
    48 Local Institution Moscow Russian Federation 143423
    49 Local Institution Port Elizabeth Eastern Cape South Africa 6045
    50 Local Institution Pretoria Gauteng South Africa 0002
    51 Local Institution Cape Town Western Cape South Africa 7570
    52 Local Institution Cape Town Western Cape South Africa 7925
    53 Local Institution Rondebosch Western Cape South Africa 7700
    54 Local Institution Manchester Greater Manchester United Kingdom M23 9LT
    55 Local Institution Leeds West Yorkshire United Kingdom LS9 7TF

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00850577
    Other Study ID Numbers:
    • CA196-005
    • EUDRACT# 2008-007768-41
    First Posted:
    Feb 25, 2009
    Last Update Posted:
    Oct 12, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Paclitaxel
    Bevacizumab
    Carboplatin
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Oct 12, 2015