Patients with histologically proven inoperable locally advanced or metastatic gastric cancer
Conditions
Interventions
Trade Name: Erbitux
Product Name: Erbitux
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
Trade Name: Campto
Pharmaceutical Form:
Trade Name: Eloxatin 5mg/ml concentrate for solu
Sponsors
AGMT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent • Histologically proven gastric adenocarcinoma • Measurable or evaluable, inoperable locally advanced or metastatic disease • No previous palliative chemotherapy and/or immunotherapy • Life expectancy of more than 3 months • Age above 18 years • WHO performance status ? 2 (Appendix 1) • Negative pregnancy test (for female patients with reproduction potential and adequate contraception) • Hematological status: Leucocytes ? 3 x 109/l Platelets ? 100 x 109/l • Renal function: Serum creatinine: ? 1.5 x upper normal limit of the normal range of the laboratory Hepatic function: - Alkaline phosphatase: =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Women of child bearing potential not using a contraceptive method • Pregnant or breast-feeding women • Concomitant antitumoral treatment • Adjuvant chemotherapy with Oxaliplatin and/or Irinotecan • Prior history of chronic enteropathy, chronic diarrhea, unresolved bowel obstruction/subobstruction, or extensive abdominopelvic radiation therapy • Participation in another clinical trial with any investigational drug within 30 days prior to inclusion • Peripheral neuropathy (NCI CTC ? grade 1) • Previous malignancy other than CRC in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix • Legal incapacity or limited legal capacity • Other uncontrolled serious non malignant diseases: Uncontrolled congestive heart failure, angina pectoris, hypertension or arrhythmias, hepatic disease, history of significant neurologic or psychiatric disorders, active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate (RECIST);Secondary Objective: Overall survival time Safety Progression-free survival time Correlation with EGFR expression ;Primary end point(s): In this phase II study as primary endpoint the efficacy of the treatment combination was defined. For this purpose the response rate (RECIST) will be evaluated. As secondary endpoints the toxicity profile in combination with Quality of life will be investigated as well as time to progression and overall survival. | — |
Countries
Austria
Outcome results
None listed