A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
M.D. Anderson Cancer Center
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 years and above. There will be no upper age restriction. Because no dosing or adverse event data are currently available on the use of intraperitoneal paclitaxel in patients \<18 years of age, children are excluded from this study. 2. ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2. 3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction. 4. Adequate renal, and bone marrow function: 1. Leukocytes \>= 3,000/uL 2. Absolute neutrophil count \>= 1,500/uL 3. Platelets \>= 60,000/Ul 4. Serum creatinin…
Interventions
- DrugPaclitaxel
Given by IP (Intraperitoneal injection)
- DrugDexamethasone
Given by IV (vein)
- DrugDiphenhydramine
Given by IV (vein)
- DrugFamotidine
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas