Phase I/II, Multicenter, Single-Arm Clinical Trial of Panitumumab in Combination with Cisplatin, Fluourouracil and Docetaxel (DCF) in Locally Advanced or Metastatic Cancer of the Stomach and Gastro-oesophageal junction. - N/A

Hellenic Oncology Research Group (HORG)0 sitesOctober 4, 2010

Overview

No summary available.

Registry

who.int

Start Date

October 4, 2010

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Hellenic Oncology Research Group (HORG)

•1\. Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
•2\. Age between 20 and 70 years old
•3\. Measurable disease defined by RECIST
•4\. Patients with non\-measurable disease could be enrolled in the phase I part of the study.
•5\. ECOG performance status \= 1
•6\. Hgb \= 8g/dL, WBC \= 3 x 109/L , neutrophils count \= 1\.5 x 109/L , platelets \=100 x 109/L ,
•7\. Creatinine clearance \=50 mL/min
•8\. Total bilirubin \= 1\.5 X UNL
•9\. AST, ALT and ALP \= 2\.5 x UNL
•10\. No prior chemotherapy or more than six months from adjuvant chemotherapy or chemoradiation

•1\. Gastrointestinal bleeding
•2\. Clinically relevant, symptomatic excessive amounts of ascites resulting in patient’s discomfort
•3\. CNS metastases
•4\. History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds
•5\. Any previous chemotherapy or radiotherapy for advanced disease
•6\. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
•7\. 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.
•8\. Known hypersensitivity reaction to the component of the treatment.
•9\. Active infection or malnutrition or bowel obstruction.
•10\. Legal incapacity or limited legal capacity