Study on Sequential Systemic Therapy and Intraperitoneal Paclitaxel for Stomach and Gastroesophageal Cancer with Peritoneal Spread

Sponsor: University of California, Irvine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04762953

Provider View

This clinical trial is testing a combination of chemotherapy treatments given both through the bloodstream and directly into the abdomen to see if it can effectively treat stomach and gastroesophageal cancer that has spread to the lining of the abdomen.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of combining two types of chemotherapy: one given through the bloodstream (systemic) and the other directly into the abdominal cavity (intraperitoneal) for patients with stomach or gastroesophageal cancer that has spread to the abdominal lining. Patients will first receive systemic chemotherapy for 3-4 months. If the cancer has not spread to distant organs, they will then receive intraperitoneal chemotherapy through a port placed in the abdomen. The treatment involves a combination of drugs, including Paclitaxel, 5-FU, and Leucovorin, administered over several cycles. The response to treatment will be assessed through imaging tests, and based on the results, further treatment options will be considered.

Description

Patients with confirmed stomach or gastroesophageal cancer that has spread to the abdominal lining, but not to distant organs, can participate in this study. Initially, patients will receive systemic chemotherapy for 3-4 months, tailored to their specific cancer markers. If the cancer has not progressed to distant organs, they will undergo a procedure to place a port in the abdomen for intraperitoneal chemotherapy. This involves administering Paclitaxel directly into the abdominal cavity on specific days, repeated every 21 days for 3 months. After completing this treatment, imaging tests will be conducted to evaluate the cancer's response. Depending on the results, patients may continue with the same treatment, switch to a different regimen, or undergo surgery if the cancer is significantly reduced and surgery is feasible.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed stomach or gastroesophageal cancer and have completed at least three months of initial chemotherapy without the cancer spreading to distant organs.
  • Must have cancer spread to the abdominal lining, confirmed by imaging or surgical procedures.
  • Age between 18 and 75 years.
  • Must be in relatively good health, with a performance status score of 2 or less, meaning able to carry out light work or daily activities.
  • Must have a life expectancy of more than 6 months.
  • Must have adequate blood cell counts and organ function, including:
    • White blood cells of at least 2,000/mcL.
    • Neutrophil count of at least 1,500/mcL.
    • Platelet count of at least 80,000/mcL.
    • Normal bilirubin levels.
    • Liver enzymes within specified limits.
    • Creatinine levels within specified limits.
    • Hemoglobin level above 8.0 g/dL.
    • Serum albumin level of at least 3.0 g/dL.
  • Must understand and agree to sign a written informed consent.

Exclusion Criteria

  • Have received more than three months of treatment for cancer that cannot be surgically removed or has spread to distant organs.
  • Have cancer that has spread to distant organs like the liver, lungs, brain, or bones.
  • Have extensive lymph node involvement that cannot be surgically removed.
  • Have bowel obstruction, except for blockage caused by the primary cancer.
  • Have uncontrolled illnesses, such as:
    • Active infections.
    • Heart failure or recent heart attack.
    • Recent stroke or other serious heart conditions.
  • Have had another primary cancer within the last 3 years, except for certain skin or prostate cancers or treated cervical cancer.
  • Cannot comply with study procedures or follow-up visits.
  • Must not be pregnant or nursing, and must agree to use effective birth control during and after the study.
  • Have an active infection requiring treatment.
  • Have had prior surgery that prevents safe placement of the abdominal port.
  • Have a history of active tuberculosis.
  • Have any condition or treatment that could interfere with the study results or participation.

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