This phase II clinical trial tests how well paclitaxel given within the abdomen (intraperitoneal) around the time of surgery (perioperative) works for the treatment of patients with gastric or gastroesophageal adenocarcinoma with carcinomatosis or positive cytology that has spread from where it first started (primary site) to other places in the body (stage IV). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Giving perioperative intraperitoneal paclitaxel may kill more tumor cells in patients with stage IV gastric or gastroesophageal adenocarcinoma with carcinomatosis or positive cytology.
Additional locations may be listed on ClinicalTrials.gov for NCT05977998.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Brian D. Badgwell
Phone: 713-745-7351
PRIMARY OBJECTIVE:
I. To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after perioperative intraperitoneal paclitaxel and gastrectomy.
SECONDARY OBJECTIVE:
I. To assess the safety of gastrectomy in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis undergoing treatment with perioperative intraperitoneal paclitaxel.
OUTLINE:
Patients receive paclitaxel intraperitoneally (IP) over at least 30 minutes every other week for a total of 3 treatments in the absence of disease progression or unacceptable toxicity. Patients then receive no treatment for a minimum of 3 weeks and are evaluated for surgery. Patients who undergo standard of care (SOC) gastrectomy may resume treatment at 3 weeks postoperative and receive paclitaxel IP over at least 30 minutes every other week for an additional 3 treatments in the absence of disease progression or unacceptable toxicity.
Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI) or position emission tomography (PET)/CT during screening and follow-up.
After completion of study treatment, patients follow up every 6 months for up to 3 years after the last patient is enrolled.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBrian D. Badgwell