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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

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
CT-322
Bevacizumab
Bevacizumab placebo (ie saline solution)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Acrc/Arizona Clinical Research Center, Inc.
  • Sharp Clinical Oncology Research
  • Cancer Institute Of Florida
  • Palm Beach Cancer Institute
  • Clintell, Inc.
  • Cancer Center Of Kansas
  • Kentucky Cancer Clinic
  • Annapolis Oncology Center
  • Meritus Center For Clinical Research
  • North Mississippi Hematology And Oncology Associates, Ltd
  • Piedmont Hematology Oncology Associates, Pllc
  • North Canton Medical Clinic Center
  • Kaiser Permanente Oncology/Hematology
  • Guthrie Clinic, Ltd
  • Rhode Island Hospital
  • Charleston Hematology Oncology Associates, Pa
  • Cancer Center At Cookeville Regional Medical Center
  • University Of Tennessee Cancer Institute
  • Blue Ridge Cancer Care
  • Providence Western Washington Oncology
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Paclitaxel/Carboplatin/CT-322

Paclitaxel/Carboplatin/Bevacizumab/Placebo

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival based on tumor assessments (CT scans/MRI)

Secondary Outcome Measures

Overall survival (OS) between 2 arms
Objective tumor response rate (ORR) between 2 arms
Safety in the CT-322 plus carboplatin and paclitaxel arm

Full Information

First Posted
February 23, 2009
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00850577
Brief Title
Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel/Carboplatin/CT-322
Arm Type
Active Comparator
Arm Title
Paclitaxel/Carboplatin/Bevacizumab/Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Solution, IV, 200 mg/m2, Q21days, 6 cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Solution, IV, AUC=6, Q21days, 6 cycles
Intervention Type
Drug
Intervention Name(s)
CT-322
Other Intervention Name(s)
BMS-844203
Intervention Description
Solution, IV, 2 mg/kg, Q7days, Until PD
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Solution, IV, 15 mg/kg, Q21days, Until PD
Intervention Type
Drug
Intervention Name(s)
Bevacizumab placebo (ie saline solution)
Other Intervention Name(s)
Saline solution
Intervention Description
Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Overall survival (OS) between 2 arms
Time Frame
every 12 weeks
Title
Objective tumor response rate (ORR) between 2 arms
Time Frame
every 6 weeks
Title
Safety in the CT-322 plus carboplatin and paclitaxel arm
Time Frame
weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Acrc/Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Cancer Institute Of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Clintell, Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Cancer Center Of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Annapolis Oncology Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Meritus Center For Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
North Mississippi Hematology And Oncology Associates, Ltd
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Piedmont Hematology Oncology Associates, Pllc
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
North Canton Medical Clinic Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Kaiser Permanente Oncology/Hematology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Guthrie Clinic, Ltd
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Charleston Hematology Oncology Associates, Pa
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Cancer Center At Cookeville Regional Medical Center
City
Cookeville
State/Province
Tennessee
ZIP/Postal Code
38501
Country
United States
Facility Name
University Of Tennessee Cancer Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Providence Western Washington Oncology
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
Local Institution
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60336550
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Local Institution
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Local Institution
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Local Institution
City
Meldola (Fc)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Local Institution
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Local Institution
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
Local Institution
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60 569
Country
Poland
Facility Name
Local Institution
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Local Institution
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Local institution
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115 478
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Local Institution
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Local Institution
City
Rondebosch
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Local Institution
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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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