NCT02251951

Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer

A Multicenter, Phase II, Single-Arm Clinical Trial of Nab-Paclitaxel as Salvage Treatment for Patients With Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal Junction.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction

Detailed description

Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. The promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage treatment for patients with advanced cancer of the stomach and GEJ previously treated with the DCF regimen.

Conditions

• Stomach and Gastro-Esophageal Junction (GEJ) Cancer

Interventions

Type	Name	Description
DRUG	nab-Paclitaxel	Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d)

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-09-29
• Last updated: 2015-10-08

Locations

6 sites across 1 country: Greece