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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 HospitalProvidence, Rhode Island  02903
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
ACRC/Arizona Clinical Research Center, Inc.Tucson, Arizona  85712
Kentucky Cancer ClinicPikeville, Kentucky  41501
Annapolis Oncology CenterAnnapolis, Maryland  21401
Sharp Clinical Oncology ResearchSan Diego, California  92123
Cancer Center of KansasWichita, Kansas  67214
Kaiser Permanente Oncology/HematologyPortland, Oregon  97227
Charleston Hematology Oncology Associates, PACharleston, South Carolina  29403
Blue Ridge Cancer CareRoanoke, Virginia  24019
Providence Western Washington OncologyLacey, Washington  98503
Clintell, Inc.Skokie, Illinois  60077
Piedmont Hematology Oncology Associates, PAWinston Salem, North Carolina  27103
North Mississippi Hematology And Oncology Associates, LtdTupelo, Mississippi  38801
Cancer Institute Of FloridaOrlando, Florida  32804
Meritus Center For Clinical ResearchHagerstown, Maryland  21740
North Canton Medical Clinic CenterCanton, Ohio  44710
Guthrie Clinic, LtdSayre, Pennsylvania  18840
Cancer Center At Cookeville Regional Medical CenterCookeville, Tennessee  38501