Selumetinib and Paclitaxel as Second-Line Treatment in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer

Conditions

• Stage IIIB Non-Small Cell Lung Cancer AJCC v7
• Stage IV Non-Small Cell Lung Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Paclitaxel — DRUG
  Given IV
• Pharmacological Study — OTHER
  Correlative studies
• Selumetinib — DRUG
  Given PO

Study Details

This randomized phase I trial is studying the side effects and the best dose of selumetinib when given together with paclitaxel as a second line therapy in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Selumetinib may stop or slow the growth of tumor cells by blocking a protein called mitogen-activated protein kinase (MEK) that is needed for cell growth. Drugs used in chemotherapy, such as 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. Giving selumetinib together with paclitaxel may kill more tumor cells.

Key Dates

Start date

Jul 21, 2016

Status verified

Mar 2023

Primary completion

Jul 16, 2020

Completion

Jul 16, 2020

Study Design

Enrollment

23 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (continuous selumetinib and paclitaxel)
  Patients receive selumetinib PO BID on days 1-21 and paclitaxel IV over a fixed rate on days 1 and 8.
• Experimental: Arm II (intermittent selumetinib and paclitaxel)
  Patients receive selumetinib PO BID on days 1-5, 8-12, and 15-19 and paclitaxel as in Arm I.
• Experimental: Arm III (pulsatile selumetinib and paclitaxel)
  Patients receive selumetinib PO BID on days 1-3, 8-10, and 15-17 and paclitaxel as in Arm I.

Primary Outcome Measure

Incidence of grade 3 or higher treatment-related adverse event (AE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days post-treatment ]

Locations (1)

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