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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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