Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer

Status Active, not recruiting

Clinical Trial Summary

This phase I trial studies the side effects and best dose of paclitaxel for the treatment of gastric or gastroesophageal cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To assess the maximum tolerated dose (MTD) of paclitaxel via intraperitoneal route in subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis. SECONDARY OBJECTIVES: I. Safety and tolerability of escalating doses of intraperitoneal paclitaxel in subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis. II. To make a preliminary assessment of the anti-tumor activity of paclitaxel in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis. OUTLINE: This is a dose-escalation study. Patients receive paclitaxel intraperitoneally (IP) over 1 hour once weekly during weeks 1-3 and 5-7 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 5 years. ;

Study Design

Related Conditions & MeSH terms

Adenocarcinoma
Carcinoma
Clinical Stage IV Gastric Cancer AJCC v8
Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IVA Gastric Cancer AJCC v8
Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IVB Gastric Cancer AJCC v8
Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
Esophageal Neoplasms
Metastatic Gastric Adenocarcinoma
Metastatic Gastroesophageal Junction Adenocarcinoma
Pathologic Stage IV Gastric Cancer AJCC v8
Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
Peritoneal Carcinomatosis
Peritoneal Neoplasms
Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
Stomach Neoplasms

Clinical Trial Details

NCT number	NCT04220827
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	December 6, 2019
Completion date	October 30, 2028

View Details

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