Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01912625
Phase
PHASE1
Status
Terminated

Conditions

  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage III Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIA Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIB Lung Non-Small Cell Cancer AJCC v7

Eligibility Criteria

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

Interventions

  • 3-Dimensional Conformal Radiation Therapy — RADIATION
    Undergo 3D-CRT
  • Carboplatin — DRUG
    Given IV
  • Image Guided Radiation Therapy — RADIATION
    Undergo IGRT
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Paclitaxel — DRUG
    Given IV
  • Pharmacological Study — OTHER
    Correlative studies
  • Trametinib — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and the best dose of trametinib when given together with combination chemotherapy and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving trametinib, combination chemotherapy, and radiation therapy may be a better treatment for non-small cell lung cancer.

Key Dates

Start date
Oct 28, 2013
Status verified
May 2023
Primary completion
Nov 3, 2017
Completion
Feb 24, 2023

Study Design

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

Arms

  • Experimental: Treatment (trametinib, chemotherapy, radiation therapy)
    CONCURRENT CHEMOTHERAPY: Patients undergo IMRT or 3D-CRT QD 5 days a week for 6 weeks. Patients receive trametinib PO QD and carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients without disease progression after completion of chemoradiation proceed to consolidation chemotherapy. CONSOLIDATION CHEMOTHERAPY: Beginning 3 weeks after completion of concurrent chemoradiation, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 1 and 22. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Dose limiting toxicity defined as any grade 3 or 4 non-hematologic toxicities according to Common Terminology Criteria for Adverse Events version 4.0 grading [ Time Frame: Within 70 days from the start of radiation therapy ]

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-
Case Western Reserve UniversityClevelandOhio44106-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
M D Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Rochester, MN

By research site
Mayo Clinic in Rochester· Rochester, MNCase Western Reserve University· Cleveland, OHOhio State University Comprehensive Cancer Center· Columbus, OHM D Anderson Cancer Center· Houston, TXUniversity of Wisconsin Carbone Cancer Center· Madison, WI

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