Phase III Study of Intraperitoneal Paclitaxel for Adults With Metastatic Appendiceal Adenocarcinoma

What this Trial Is About

Researchers are investigating the use of paclitaxel delivered directly into the abdominal cavity intraperitoneally to treat patients with metastatic appendiceal adenocarcinoma, a type of cancer that has spread within the peritoneal cavity. This Phase III study aims to find the maximum tolerated dose and evaluate the drugs effect on tumor response, survival, and other biological markers in participants with this condition. Participants will be assigned to either Phase I or Phase II based on when they join the study. In Phase I, small groups receive increasing doses of intraperitoneal paclitaxel every 14 days to identify the highest dose without intolerable side effects. Phase II participants receive paclitaxel at the recommended dose found in Phase I. Additionally, some supportive drugs like dexamethasone, diphenhydramine, and famotidine are given orally. The study will also assess various biological and genetic factors related to the cancer. During the study, participants will be monitored for safety and side effects throughout treatment and for about one year. Researchers will evaluate tumor response using pathology and imaging, track progression-free and overall survival, and study changes in circulating tumor DNA and other markers. Participants organ function and symptoms will be assessed, with ongoing safety checks until study completion. The total participation time varies depending on individual treatment and follow-up.

A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma