Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer

Part of paid clinical trials in Casa Grande, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT01109524
Phase
PHASE2
Status
Completed

Conditions

  • Cancer of the Lung
  • Carcinoma
  • Lung Neoplasms
  • Non-Small-Cell Lung Carcinoma

Eligibility Criteria

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

Interventions

  • Cetuximab — DRUG
    Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
  • Cisplatin — DRUG
    Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
  • Vinorelbine — DRUG
    Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles

Study Details

The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.

Key Dates

Start date
Jul 31, 2010
Status verified
Nov 2015
Primary completion
Sep 30, 2012
Completion
Sep 30, 2012

Study Design

Enrollment
72 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cetuximab + Cisplatin + Vinorelbine

Primary Outcome Measure

Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population [ Time Frame: Day 1 up to 30 days after last dose ]

Locations (13)

FacilityCityStateZIPSite coordinators
Donald W. Hill M.D., P.C.Casa GrandeArizona85122-
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
Cancer Care InstituteLos AngelesCalifornia90036-
Northern California Hematology & OncologyOaklandCalifornia94609-
Sharp Clinical Oncology ResearchSan DiegoCalifornia92123-
Broward Oncology Associates, P.A.Fort LauderdaleFlorida33308-
Elite Research InstituteMiamiFlorida33125-
Edward H. Kaplan, MD & AssociatesSkokieIllinois60076-
Fairview Southdale Medical Oncology ClinicEdinaMinnesota55435-
Mid Dakota Clinic, PcBismarckNorth Dakota58501-
Temple University HospitalPhiladelphiaPennsylvania19140-
University Medical CenterLubbockTexas79415-
Columbia Basin Hematology and OncologyKennewickWashington99336-

Find similar trials in Casa Grande, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Donald W. Hill M.D., P.C.· Casa Grande, AZBeverly Hills Cancer Center· Beverly Hills, CACancer Care Institute· Los Angeles, CANorthern California Hematology & Oncology· Oakland, CASharp Clinical Oncology Research· San Diego, CABroward Oncology Associates, P.A.· Fort Lauderdale, FL

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