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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d)
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
Overall Response Rate
Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
Time frame: Disease evaluation every 8 weeks up to 108 weeks
Disease control rate
Documented disease control rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
Time frame: Disease evaluation every 8 weeks up to 108 weeks
Progression Free Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 108 weeks
Time frame: Up to 108 weeks
Overall Survival
From date of randomization until the date of last follow up or death from any cause, assessed up to 108 weeks
Time frame: Up to 108 weeks
Number of Participants with Adverse Events
Time frame: Every two weeks up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
"Ag. Georgios" General Hospital of Chania
Chania, Greece
"PAPAGEORGIOY" General Hospital of Thessaloniki
Thessaloniki, Greece