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Brief Title: Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer
Official Title: 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.
Study ID: NCT02251951
Brief 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.
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece, Heraklion, Crete, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, , Greece
Air Forces Military Hospital of Athens Athens, Greece, Athens, , Greece
SOTIRIA Hospital, Medical Oncology Department, Athens, , Greece
"Ag. Georgios" General Hospital of Chania, Chania, , Greece
"PAPAGEORGIOY" General Hospital of Thessaloniki, Thessaloniki, , Greece
Name: John Souglakos, MD
Affiliation: University Hospital of Herklion
Role: PRINCIPAL_INVESTIGATOR
Name: Vassilis Georgoulias, MD
Affiliation: University Hospital of Heraklion
Role: PRINCIPAL_INVESTIGATOR