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

Hellenic Oncology Research Group

Status and phase

Completed

Phase 2

Conditions

Stomach and Gastro-Esophageal Junction (GEJ) Cancer

Treatments

Drug: nab-Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT02251951

CT/12.05

Details and patient eligibility

About

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

Full 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.

Enrollment

39 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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