Study on Personalized Cancer Treatment Using Genetic Profiling for Advanced Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02152254

Provider View

This clinical trial is exploring whether using genetic information from a patient's tumor to choose targeted therapy is more effective than standard treatment for cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to find out if selecting cancer treatment based on the genetic makeup of a patient's tumor can lead to better outcomes compared to standard treatments. By analyzing the genetic changes in the tumor, doctors can choose a targeted therapy that may be more effective for each individual patient. This approach is being tested against the usual treatment methods to see which works better for patients with metastatic cancer.

Description

The main goal of this study is to see if patients who receive a targeted therapy based on their tumor's genetic profile have longer periods without cancer progression compared to those who receive standard treatment. When patients join the study, their tumor will be analyzed to identify any genetic changes. Based on these results, patients will be randomly assigned to one of two groups:

  • Group 1 (Matched Targeted Therapy): Patients receive a treatment specifically chosen to target the genetic changes found in their tumor. This may involve participating in a clinical trial for a new drug or receiving an FDA-approved drug for another condition.

  • Group 2 (Other Therapy): Patients receive the standard treatment as decided by their doctor.

If the cancer progresses, patients can switch to the other treatment group.

The study will help determine if using genetic information to guide treatment decisions can improve outcomes for patients with advanced cancer.

Eligibility Criteria

Inclusion Criteria

  • Have cancer that has spread to other parts of the body (metastatic cancer).
  • May have had any number of previous treatments.
  • Must have tried standard treatments or decided not to use them.
  • Have measurable cancer that can be tracked.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have a tumor that can be biopsied, unless recent surgery provides enough tissue for analysis.
  • Meet specific blood count and organ function requirements.
  • If there are brain metastases, they must be stable and not require steroids.
  • Agree to use effective birth control if of childbearing potential.
  • Have signed informed consent to participate in the study.

Exclusion Criteria

  • Cannot receive treatment based on previous genetic profiling if assigned to the standard treatment group.
  • Must not have had recent chemotherapy, surgery, or radiation within 3 weeks (4 weeks for certain drugs) before starting the study treatment.
  • Cannot have certain heart conditions or uncontrolled high blood pressure.
  • Cannot have severe nerve damage or be pregnant or breastfeeding.
  • Must not have uncontrolled medical conditions that could interfere with the study.
  • Must be able to swallow pills if the treatment is taken orally.
  • Any other condition that might make participating in the study unsafe or difficult.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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