Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00850577
Phase
PHASE2
Status
Terminated

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Solution, IV, 200 mg/m2, Q21days, 6 cycles
  • Carboplatin — DRUG
    Solution, IV, AUC=6, Q21days, 6 cycles
  • CT-322 — DRUG
    Solution, IV, 2 mg/kg, Q7days, Until PD
  • Bevacizumab — DRUG
    Solution, IV, 15 mg/kg, Q21days, Until PD
  • Bevacizumab placebo (ie saline solution) — DRUG
    Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD

Study Details

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

Key Dates

First listed
Feb 25, 2009
Start date
Jun 30, 2009
Status verified
Sep 2015
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
255 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Paclitaxel/Carboplatin/CT-322
  • Active Comparator: Paclitaxel/Carboplatin/Bevacizumab/Placebo

Primary Outcome Measure

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 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Acrc/Arizona Clinical Research Center, Inc.TucsonArizona85715-
Sharp Clinical Oncology ResearchSan DiegoCalifornia92123-
Cancer Institute Of FloridaOrlandoFlorida32804-
Palm Beach Cancer InstituteWest Palm BeachFlorida33401-
Clintell, Inc.SkokieIllinois60077-
Cancer Center Of KansasWichitaKansas67214-
Kentucky Cancer ClinicHazardKentucky41701-
Annapolis Oncology CenterAnnapolisMaryland21401-
Meritus Center For Clinical ResearchHagerstownMaryland21740-
North Mississippi Hematology And Oncology Associates, LtdTupeloMississippi38801-
Piedmont Hematology Oncology Associates, PllcWinston-SalemNorth Carolina27103-
North Canton Medical Clinic CenterCantonOhio44710-
Kaiser Permanente Oncology/HematologyPortlandOregon97227-
Guthrie Clinic, LtdSayrePennsylvania18840-
Rhode Island HospitalProvidenceRhode Island02903-
Charleston Hematology Oncology Associates, PaCharlestonSouth Carolina29414-
Cancer Center At Cookeville Regional Medical CenterCookevilleTennessee38501-
University Of Tennessee Cancer InstituteMemphisTennessee38104-
Blue Ridge Cancer CareChristiansburgVirginia24073-
Providence Western Washington OncologyLaceyWashington98503-

Find similar trials in Tucson, AZ

By research site
Acrc/Arizona Clinical Research Center, Inc.· Tucson, AZSharp Clinical Oncology Research· San Diego, CACancer Institute Of Florida· Orlando, FLPalm Beach Cancer Institute· West Palm Beach, FLClintell, Inc.· Skokie, ILCancer Center Of Kansas· Wichita, KS

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