Intraperitoneal Paclitaxel for Stomach Cancer

(STOPGAP II Trial)

This trial aims to determine if adding paclitaxel, a chemotherapy drug, directly into the abdomen alongside standard chemotherapy can better control gastric cancer and extend patient survival. Participants will be divided into two groups: one will receive only standard chemotherapy, while the other will receive both standard chemotherapy and paclitaxel through a special abdominal port. This approach may benefit those previously treated for gastric or gastroesophageal cancer who do not have cancer in other organs, such as the liver or lungs. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering hope for improved outcomes.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the study team to get guidance based on your specific situation.

Research has shown that using paclitaxel directly in the abdominal area for treating stomach cancer yields promising safety results. In one study, paclitaxel was safely administered at doses of 100 mg/m². However, some patients experienced a drop in white blood cells, known as neutropenia, which can increase the risk of infections. This side effect was common with weekly treatments.

Other studies suggest that this method might help patients live longer, which is encouraging. These safety results come from earlier trials, and the current phase of the trial aims to gather more information about the treatment's safety and effectiveness.

Intraperitoneal paclitaxel is unique because it delivers chemotherapy directly to the abdominal cavity, targeting stomach cancer cells more directly than traditional systemic treatments. Unlike standard chemotherapy options that circulate throughout the body, this method allows for higher concentrations of the drug in the tumor area with potentially fewer side effects. Researchers are excited about this approach because it could enhance treatment effectiveness and improve patient outcomes by concentrating the therapy where it's needed most, potentially leading to better control of the disease.

Research has shown that delivering paclitaxel directly into the abdomen can extend the lives of patients with stomach cancer. In this trial, participants in one arm will receive systemic therapy combined with intraperitoneal paclitaxel. Studies have found that this method, when used with standard chemotherapy, significantly improves survival rates compared to chemotherapy alone. For instance, one study found that patients who received paclitaxel both inside the abdomen and through a vein experienced much better outcomes. In another study, 78% of patients were still alive after one year, highlighting this approach's potential. These findings suggest that paclitaxel delivered into the abdomen may effectively target cancer cells, possibly leading to longer survival for those with stomach cancer.²³⁶⁷⁸