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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Brazil: Ministry of Health

Study ID:

CA196-005

NCT ID:

NCT00850577

Start Date:

February 2001

Completion Date:

August 2012

Related Keywords:

  • Non-Small Cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Rhode Island Hospital Providence, Rhode Island  02903
University of Tennessee Cancer Institute Memphis, Tennessee  38103
Palm Beach Cancer Institute West Palm Beach, Florida  33401
ACRC/Arizona Clinical Research Center, Inc. Tucson, Arizona  85712
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Annapolis Oncology Center Annapolis, Maryland  21401
Sharp Clinical Oncology Research San Diego, California  92123
Cancer Center of Kansas Wichita, Kansas  67214
Kaiser Permanente Oncology/Hematology Portland, Oregon  97227
Charleston Hematology Oncology Associates, PA Charleston, South Carolina  29403
Blue Ridge Cancer Care Roanoke, Virginia  24019
Providence Western Washington Oncology Lacey, Washington  98503
Clintell, Inc. Skokie, Illinois  60077
Piedmont Hematology Oncology Associates, PA Winston Salem, North Carolina  27103
North Mississippi Hematology And Oncology Associates, Ltd Tupelo, Mississippi  38801
Cancer Institute Of Florida Orlando, Florida  32804
Meritus Center For Clinical Research Hagerstown, Maryland  21740
North Canton Medical Clinic Center Canton, Ohio  44710
Guthrie Clinic, Ltd Sayre, Pennsylvania  18840
Cancer Center At Cookeville Regional Medical Center Cookeville, Tennessee  38501