BATTLE-FL: Front-Line Biomarker-Integrated Treatment Study in Non Small Cell Lung Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01263782
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Carboplatin — DRUG
    AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
  • Pemetrexed — DRUG
    500 mg/m2 by vein on day 1 of each 21 day cycle.
  • Bevacizumab — DRUG
    15 mg/kg by vein on day 1 of each 21 day cycle.
  • Cixutumumab — DRUG
    20 mg/kg by vein on day 1 of each 21 day cycle.

Study Details

The goal of this clinical research study is to learn if knowing biomarker status can help researchers find better treatment combinations for patients with advanced NSCLC. Researchers want to use biomarker status to decide what drug (bevacizumab, or cixutumumab) to give in combination with carboplatin and pemetrexed. The safety of these drug combinations will also be studied.

Key Dates

First listed
Dec 21, 2010
Start date
May 17, 2011
Status verified
May 2019
Primary completion
Aug 15, 2017
Completion
Aug 15, 2017

Study Design

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

Arms

  • Experimental: Carboplatin + Pemetrexed
    The chemotherapy will be Carboplatin (AUC 6) and Pemetrexed (500 mg/m2) every 3 weeks for 4 cycles. Then maintenance Pemetrexed (500 mg/m2 every 3 weeks) will be administered until disease progression or excessive toxicity. If patients are randomized into one of the arms with a biologic therapy, patients will take the chemotherapy prescribed above, but will also receive the biologic therapy during the same time period.
  • Experimental: Chemo (Carbo/Peme) + Bevacizumab
    Carboplatin AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles. Pemetrexed 500 mg/m2 by vein on day 1 of each 21 day cycle. Bevacizumab 15 mg/kg by vein on day 1 of each 21 day cycle.
  • Experimental: Chemo (Carbo/Peme)
    Carboplatin AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles. Pemetrexed 500 mg/m2 by vein on day 1 of each 21 day cycle.
  • Experimental: Chemo (Carbo/Peme) + Cixutumumab
    Carboplatin AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles. Pemetrexed 500 mg/m2 by vein on day 1 of each 21 day cycle. Cixutumumab 20 mg/kg by vein on day 1 of each 21 day cycle.

Primary Outcome Measure

Progression Free Survival [ Time Frame: From treatment start to the time of progression or death, whichever occurred first, or to the time of last contact, assessed up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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