Phase II Study of Paclitaxel and Surgery for Stomach Cancer with Spread to the Abdomen or Positive Cancer Cells

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05977998

Provider View

This clinical trial is exploring the effects of the drug paclitaxel, given before surgery, on improving outcomes for patients with stomach cancer that has spread to the abdomen or has positive cancer cells. The study also looks at the safety of surgery in these patients.

Patient Parameters

Program Overview

The aim of this study is to understand how the drug paclitaxel, used before surgery to remove part or all of the stomach, can help improve survival in patients with advanced stomach or gastroesophageal cancer. The study will also evaluate the safety of performing surgery in these patients.

Description

This study focuses on patients with advanced stomach or gastroesophageal cancer that has spread to the abdomen or has positive cancer cells. The main goal is to see if using the drug paclitaxel before surgery can improve survival rates. Researchers will also assess the safety of the surgery in these patients.

Participants will receive paclitaxel directly into the abdomen before undergoing surgery to remove the stomach or part of it. The study will monitor overall survival from the time of diagnosis and evaluate any side effects related to the surgery.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older. There is no upper age limit.
  • Must have a performance status score of 2 or less, indicating the ability to carry out light work or be fully active.
  • Must have a confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction.
  • Must have adequate kidney and bone marrow function, as shown by specific blood tests:
    • White blood cell count of at least 3,000/uL
    • Neutrophil count of at least 1,500/uL
    • Platelet count of at least 60,000/uL
    • Serum creatinine of 1.6 mg/dL or less
  • Must have cancer that has spread to the abdomen, shown by:
    • Positive cancer cells in the abdomen, or
    • Cancer spread seen during diagnostic surgery.
  • Must have completed preoperative chemotherapy. Targeted therapies and immunotherapies may continue.
  • Both English and non-English speaking patients can participate.

Exclusion Criteria

  • Cancer that has spread to organs like the liver, brain, or lungs.
  • Active infections like pneumonia or wound infections that would prevent treatment.
  • Women who are pregnant or breastfeeding cannot participate. Women of childbearing age must use effective birth control and men must agree to use birth control methods.
  • Patients with unstable heart conditions or severe heart failure.
  • Patients who cannot follow study procedures due to cognitive impairment.
  • Patients with severe allergic reactions to chemotherapy that were life-threatening or caused significant disability.
  • Previous surgeries that would make it unsafe to perform the planned surgery and treatment.

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