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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

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ClinicalTrials.gov Identifier: NCT00850577
Recruitment Status : Terminated
First Posted : February 25, 2009
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Non-small Cell Lung Cancer (NSCLC) Drug: Paclitaxel Drug: Carboplatin Drug: CT-322 Drug: Bevacizumab Drug: Bevacizumab placebo (ie saline solution) Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : June 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Paclitaxel/Carboplatin/CT-322 Drug: Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Other Name: Taxol

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

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

Active Comparator: Paclitaxel/Carboplatin/Bevacizumab/Placebo Drug: Paclitaxel
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Other Name: Taxol

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

Drug: Bevacizumab
Solution, IV, 15 mg/kg, Q21days, Until PD
Other Name: 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 Name: Saline solution




Primary Outcome Measures :
  1. Progression free survival based on tumor assessments (CT scans/MRI) [ Time Frame: 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 [ Time Frame: every 12 weeks ]
  2. Objective tumor response rate (ORR) between 2 arms [ Time Frame: every 6 weeks ]
  3. Safety in the CT-322 plus carboplatin and paclitaxel arm [ Time Frame: weekly ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850577


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Locations
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United States, Arizona
Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85715
United States, California
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Florida
Cancer Institute Of Florida
Orlando, Florida, United States, 32804
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Illinois
Clintell, Inc.
Skokie, Illinois, United States, 60077
United States, Kansas
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Maryland
Annapolis Oncology Center
Annapolis, Maryland, United States, 21401
Meritus Center For Clinical Research
Hagerstown, Maryland, United States, 21740
United States, Mississippi
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, United States, 38801
United States, North Carolina
Piedmont Hematology Oncology Associates, Pllc
Winston-salem, North Carolina, United States, 27103
United States, Ohio
North Canton Medical Clinic Center
Canton, Ohio, United States, 44710
United States, Oregon
Kaiser Permanente Oncology/Hematology
Portland, Oregon, United States, 97227
United States, Pennsylvania
Guthrie Clinic, Ltd
Sayre, Pennsylvania, United States, 18840
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, United States, 29414
United States, Tennessee
Cancer Center At Cookeville Regional Medical Center
Cookeville, Tennessee, United States, 38501
University Of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38104
United States, Virginia
Blue Ridge Cancer Care
Christiansburg, Virginia, United States, 24073
United States, Washington
Providence Western Washington Oncology
Lacey, Washington, United States, 98503
Brazil
Local Institution
Fortaleza, Ceara, Brazil, 60336550
Local Institution
Belo Horizonte, Minas Gerais, Brazil, 30130-100
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Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
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Barretos, Sao Paulo, Brazil, 14784-400
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Rio De Janeiro, Brazil, 20231-050
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Sao Paulo, Brazil, 04024-002
Local Institution
Sao Paulo, Brazil, 05403-000
France
Local Institution
Marseille Cedex 20, France, 13915
Local Institution
Paris, France, 75005
Local Institution
Rennes Cedex 9, France, 35033
Local Institution
Toulouse Cedex 9, France, 31059
Local Institution
Tours Cedex, France, 37044
Italy
Local Institution
Meldola (Fc), Italy, 47014
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Ravenna, Italy, 48100
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Rimini, Italy, 47900
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Roma, Italy, 00189
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Terni, Italy, 05100
Poland
Local Institution
Bialystok, Poland, 15-540
Local Institution
Gdansk, Poland, 80952
Local Institution
Otwock, Poland, 05-400
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Poznan, Poland, 60 569
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Szczecin, Poland, 70-891
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Warsaw, Poland, 02-781
Russian Federation
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Chelyabinsk, Russian Federation, 454087
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Ivanovo, Russian Federation, 153013
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Moscow, Russian Federation, 115 478
Local Institution
Moscow, Russian Federation, 115478
Local Institution
Moscow, Russian Federation, 143423
South Africa
Local Institution
Port Elizabeth, Eastern Cape, South Africa, 6045
Local Institution
Pretoria, Gauteng, South Africa, 0002
Local Institution
Cape Town, Western Cape, South Africa, 7570
Local Institution
Cape Town, Western Cape, South Africa, 7925
Local Institution
Rondebosch, Western Cape, South Africa, 7700
United Kingdom
Local Institution
Manchester, Greater Manchester, United Kingdom, M23 9LT
Local Institution
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00850577     History of Changes
Other Study ID Numbers: CA196-005
EUDRACT# 2008-007768-41
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Pharmaceutical Solutions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors