Status:
COMPLETED
Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Conditions:
Stomach and Gastro-Esophageal Junction (GEJ) Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 ju...
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 res...
Eligibility Criteria
Inclusion
- Age \>18 years old
- Disease progression after treatment with the DCF regimen
- Assessable target lesion(s) as defined by RECIST criteria
- ECOG performance status ≤ 1
- Estimated life expectancy more than 3 months
- Serum bilirubin less than 1.5 times the upper normal limit
- Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit
- Creatinine Clearance ≥50 ml/min
- Neutrophil count more than 1.5x 109 /L
- Platelet count more than 100x 109 /L
- Hemoglobin more than 8g/dL
- Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.
Exclusion
- Gastrointestinal bleeding
- Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
- CNS metastases
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
- Known hypersensitivity reaction to the component of the treatment
- Active infection or malnutrition or bowel obstruction
- Legal incapacity or limited legal capacity
- Definite contraindications for the use of corticosteroids
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- Chronic inflammation of the bowel
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
- Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
- Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02251951
Start Date
September 1 2012
End Date
June 1 2015
Last Update
October 8 2015
Active Locations (6)
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1
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
Heraklion, Crete, Greece
2
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
3
Air Forces Military Hospital of Athens Athens, Greece
Athens, Greece
4
SOTIRIA Hospital, Medical Oncology Department
Athens, Greece