This is a phase I/II study in order to evaluate the effect of adding panitumumab to an active regimen such as DCF in the treatment of chemotherapy - naive patients with advanced cancer of the stomach.
Conditions
Interventions
Product Name: Panitumumab
Product Code: -
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Panitumumab
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Hellenic Oncology Research Group (HORG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 11. Estimated life expectancy more than 3 months 12. Paraffin-embedded block available for K-RAS central mutation analysis 13. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 11. Definite contraindications for the use of corticosteroids 12. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. 13. Chronic inflammation of the bowel. 14. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment 15. 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. 16. A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the MTD of the combination and the recommended doses for the phase II of the trial (phase I part of the study) 2. To assess the objective response rate, of the combination (phase II part of the study);Secondary Objective: 1. Progression Free Survival (PFS) 2. Overall Survival 3. Safety profile 4. Correlation between k-ras mutation status and response to therapy in the context of the parallel translational study.;Primary end point(s): 1 To assess the objective response rate, of the combination | — |
Countries
Greece
Outcome results
None listed