Genetic Analysis-Guided Irinotecan Dosing in Chemotherapy for Advanced Gastroesophageal or Stomach Cancer

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02366819

Provider View

This study is exploring how genetic analysis can help determine the best dose of the chemotherapy drug irinotecan for patients with advanced gastroesophageal or stomach cancer. The goal is to improve treatment effectiveness and minimize side effects.

Patient Parameters

Program Overview

This clinical trial is testing a new approach to chemotherapy for patients with advanced gastroesophageal or stomach cancer. The treatment involves a combination of drugs, including fluorouracil, irinotecan, leucovorin, and oxaliplatin, which work together to stop cancer cells from growing and spreading. By using genetic analysis, doctors aim to find the right dose of irinotecan that each patient can handle, potentially improving the treatment's effectiveness and reducing side effects.

Description

Primary Goals:

  • To find out how often the cancer can be completely removed with surgery after treatment.
  • To see how many patients have no remaining cancer cells after receiving four cycles of the chemotherapy regimen called mFOLFIRINOX, which includes irinotecan adjusted based on genetic analysis.

Secondary Goals:

  • To measure how well the cancer responds to treatment using scans and other tests.
  • To monitor any side effects from the chemotherapy.
  • To assess any complications from surgery.
  • To track overall survival and disease-free survival from the time of diagnosis.
  • To study patterns of cancer recurrence.
  • To compare outcomes between patients with different HER2 statuses.

Treatment Plan:

  • Before Surgery: Patients receive a combination of chemotherapy drugs (oxaliplatin, leucovorin, irinotecan, and fluorouracil) through an IV. This is repeated every two weeks for four cycles, as long as the cancer does not progress and side effects are manageable.

  • Surgery: Patients undergo surgery to remove the cancer.

  • After Surgery: Starting 5-10 weeks post-surgery, patients receive the same chemotherapy regimen every two weeks for four more cycles, again depending on cancer progression and side effects.

After completing the treatment, patients will have follow-up visits every three months for two years, then every six months for three more years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with locally advanced gastroesophageal or stomach cancer, specifically in the upper or middle parts of the stomach.
  • Cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body.
  • Must have had a diagnostic procedure to check for cancer spread in the abdomen.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Eligible for surgery aimed at curing the cancer.
  • Meet specific blood count and organ function requirements.
  • Women and men must agree to use effective birth control during the study and for 30 days after the last treatment.
  • Must not be taking certain medications that interact with irinotecan, or be willing to switch to alternatives.
  • Must provide signed informed consent to participate.

Exclusion Criteria

  • Have another type of cancer, except for certain skin cancers or cervical cancer that have been treated and have a low risk of returning.
  • Have uncontrolled inflammatory bowel disease.
  • Have significant diarrhea or nerve damage.
  • Have serious medical or psychiatric conditions that increase treatment risks.
  • Have active, uncontrolled bleeding.
  • Are pregnant or breastfeeding.
  • Have had major surgery within the last four weeks.
  • Have certain genetic variations that affect irinotecan metabolism.

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