Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02044601
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Onartuzumab — DRUG
    Phase I: Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle. Phase II: Maximum tolerated dose from Phase I.
  • Erlotinib — DRUG
    Phase I and II: 150 mg by mouth every day throughout radiation, except for chemotherapy day.
  • Paclitaxel — DRUG
    Phase I and II: 45 mg/m2 by vein once a week throughout radiation for 7 weeks.
  • Carboplatin — DRUG
    Phase I and II: AUC 2 by vein once a week throughout radiation for 7 weeks.
  • Radiation Therapy — RADIATION
    Phase I and II: Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks.

Study Details

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of onartuzumab that can be given with erlotinib and standard chemoradiation (paclitaxel and carboplatin) to patients with NSCLC. The goal of Phase II is to learn if onartuzumab plus erlotinib and chemoradiation can help to control NSCLC. The safety of this drug will also be studied.

Key Dates

First listed
Jan 24, 2014
Start date
Jun 30, 2014
Status verified
Apr 2014
Primary completion
Jun 30, 2019

Study Design

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

Arms

  • Experimental: Chemoradiation + Onartuzumab
    Participants with wild-type EGFR mutation to be randomized, and may receive this regimen. Phase I: Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle. Paclitaxel 45 mg/m2 by vein once a week throughout radiation for 7 weeks. Carboplatin AUC 2 by vein once a week throughout radiation for 7 weeks. Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks. Phase II: Same regimen as in Phase I, but starting dose of Onartuzumab is maximum tolerated dose from Phase I.
  • Experimental: Chemoradiation + Erlotinib + Onartuzumab
    Participants with EGFR mutation to receive this regimen. Participants with wild-type EGFR mutation to be randomized, and may receive this regimen. Phase I: Erlotinib 150 mg by mouth every day throughout radiation, except for chemotherapy day. Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle. Paclitaxel 45 mg/m2 by vein once a week throughout radiation for 7 weeks. Carboplatin AUC 2 by vein once a week throughout radiation for 7 weeks. Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks. Phase II: Same regimen as in Phase I, but starting dose of Onartuzumab is maximum tolerated dose from Phase I.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Onartuzumab with Chemoradiation Therapy and Erlotinib [ Time Frame: 6 months ]

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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