Clinical trial NCT00850577: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Progression free survival based on tumor assessments (CT scans/MRI)
timeFrame: every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC
Secondary outcomes:
measure: Overall survival (OS) between 2 arms
timeFrame: every 12 weeks
measure: Objective tumor response rate (ORR) between 2 arms
timeFrame: every 6 weeks
measure: Safety in the CT-322 plus carboplatin and paclitaxel arm
timeFrame: weekly
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Acrc/Arizona Clinical Research Center, Inc.
state: Arizona
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Orlando
country: United States
facility: Cancer Institute Of Florida
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Skokie
country: United States
facility: Clintell, Inc.
state: Illinois
city: Wichita
country: United States
facility: Cancer Center Of Kansas
state: Kansas
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Annapolis
country: United States
facility: Annapolis Oncology Center
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center For Clinical Research
state: Maryland
city: Tupelo
country: United States
facility: North Mississippi Hematology And Oncology Associates, Ltd
state: Mississippi
city: Winston-salem
country: United States
facility: Piedmont Hematology Oncology Associates, Pllc
state: North Carolina
city: Canton
country: United States
facility: North Canton Medical Clinic Center
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Oncology/Hematology
state: Oregon
city: Sayre
country: United States
facility: Guthrie Clinic, Ltd
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, Pa
state: South Carolina
city: Cookeville
country: United States
facility: Cancer Center At Cookeville Regional Medical Center
state: Tennessee
city: Memphis
country: United States
facility: University Of Tennessee Cancer Institute
state: Tennessee
city: Christiansburg
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Lacey
country: United States
facility: Providence Western Washington Oncology
state: Washington
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Marseille Cedex 20
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Rennes Cedex 9
country: France
facility: Local Institution
city: Toulouse Cedex 9
country: France
facility: Local Institution
city: Tours Cedex
country: France
facility: Local Institution
city: Meldola (Fc)
country: Italy
facility: Local Institution
city: Ravenna
country: Italy
facility: Local Institution
city: Rimini
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Terni
country: Italy
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Otwock
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Szczecin
country: Poland
facility: Local Institution
city: Warsaw
country: Poland
facility: Local Institution
city: Chelyabinsk
country: Russian Federation
facility: Local Institution
city: Ivanovo
country: Russian Federation
facility: Local institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Port Elizabeth
country: South Africa
facility: Local Institution
state: Eastern Cape
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Rondebosch
country: South Africa
facility: Local Institution
state: Western Cape
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Leeds
country: United Kingdom
facility: Local Institution
state: West Yorkshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: