This trial studies a special kind of chemotherapy called PIPAC for patients with ovarian, uterine, appendiceal, colorectal, or gastric cancer that has spread to the lining of the abdomen. The goal is to find out how safe this treatment is and to see how effective it can be. PIPAC delivers chemotherapy in a mist form directly into the abdomen through a small tube, which may help reduce side effects compared to traditional chemotherapy.
The trial ID number is NCT04329494. It is a Phase 1 trial, which means it is looking at how safe and effective the treatment is. The trial is regulated by the FDA and aims to include about 49 participants.
Who can join
This trial is open to adults aged 18 and older, including both men and women. Participants must have confirmed cancer with peritoneal spread and meet specific health criteria. Those who have previously received certain treatments or have specific health conditions may not be able to join. The trial team will confirm who is eligible.
Conditions
Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Malignant Uterine Neoplasm, Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Gastric Carcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Metastatic Malignant Solid Neoplasm, Metastatic Ovarian Carcinoma, Pathologic Stage IV Gastric Cancer AJCC v8, Peritoneal Carcinomatosis, Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8, Stage IV Appendix Carcinoma AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Uterine Corpus Cancer AJCC v8, Stage IVA Appendix Carcinoma AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVA Uterine Corpus Cancer AJCC v8, Stage IVB Appendix Carcinoma AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Stage IVB Uterine Corpus Cancer AJCC v8, Stage IVC Appendix Carcinoma AJCC v8, Stage IVC Colorectal Cancer AJCC v8
Age group
Adult, Older adult
Sex
All sexes
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed in one of three treatment groups based on their type of cancer. Each group receives PIPAC with different chemotherapy drugs. Treatments happen every 4 to 6 weeks for up to 3 cycles, depending on how well they are doing and if there are any side effects.
Where
This trial is running at 3 locations in the United States. All of them are currently recruiting.