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

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)

FacilityCityStateZIP
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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