A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Summary
To learn about the effects of paclitaxel and gastrectomy (surgery to remove all or part of the stomach) on improving outcomes in patients with gastric cancer.
Detailed description
Primary Objectives: 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 Objectives: 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.
Arms & interventions
- DrugPaclitaxel
Given by IP (Intraperitoneal injection)
- DrugDexamethasone
Given by IV (vein)
- DrugDiphenhydramine
Given by IV (vein)
- DrugFamotidine
Given by IV (vein)
Outcome measures
Primary
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average 1 year.
Eligibility criteria
Study locations (1)
M D Anderson Cancer Center
Houston, Texas, 77030