Study on How Genetic Differences Affect Etoposide Treatment in Small Cell Lung Cancer

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Sponsor score: 0

ClinicalTrials ID:NCT01064466

Provider View

This clinical trial is investigating how genetic variations in certain genes might influence the effectiveness and side effects of the cancer drug Etoposide in patients with small cell lung cancer.

Patient Parameters

Program Overview

The study aims to understand how differences in specific genes, known as single nucleotide polymorphisms (SNPs), affect the way patients with small cell lung cancer respond to the drug Etoposide. Researchers will look at two genes: Topoisomerase II, which may influence how well the drug works, and CYP4503A4, which may affect the side effects experienced. By precisely sequencing these genes, the study hopes to find patterns that could predict treatment outcomes.

Description

This study involves 600 patients with small cell lung cancer who will be randomly divided into two groups. Each group will receive Etoposide, a chemotherapy drug, and researchers will analyze their genetic makeup to see how it affects treatment results. The study will:

  • Sequence the entire gene related to the drug target for each patient.
  • Compare genetic sequences among all participants.
  • Identify specific genetic variations (SNPs) in the genes of interest.
  • Examine how these genetic differences relate to the effectiveness and safety of Etoposide.
  • Compare genetic findings between the two patient groups to confirm any relationships between gene variations and treatment outcomes.

The goal is to better understand how genetic differences can influence cancer treatment, potentially leading to more personalized and effective therapies in the future.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with small cell lung cancer (SCLC).
  • Have had a lung tissue biopsy confirming SCLC.
  • Able to provide enough lung tissue for biopsy.
  • Participation is random and double-blind.
  • Have measurable disease.
  • Have adequate organ function.
  • Have a good overall health status.
  • Aged 24 years or older.
  • Willing to sign an informed consent form.
  • Agree to have blood drawn for the study.

Exclusion Criteria

  • Have had a lung removed (pneumonectomy).
  • Currently receiving other cancer treatments that cannot be stopped.
  • Pregnant or breastfeeding.
  • Have other serious illnesses or infections.
  • Have more than one type of cancer at the same time.
  • Have severe drug allergies.
  • Have a tendency to clot or bleed excessively.
  • Have experienced serious side effects from the drug.
  • Have conditions that prohibit the use of the drug.
  • Have not shown any therapeutic effects from the drug.
  • Must follow the most current drug label instructions.

Locations

FACILITYZIPCITYSTATE
Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 102338770120853RockvilleMaryland

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