Phase II study of Oxaliplatin / Irinotecan / Cetuximab as first line therapy in locally advanced or metastatic gastric cancer
- Conditions
- Patients with histologically proven inoperable locally advanced or metastatic gastric cancer
- Registration Number
- EUCTR2006-001989-16-AT
- Lead Sponsor
- AGMT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•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: < 2.5 x upper normal limit of the normal range of the laboratory or < 5 x if hepatic metastases were present
-total Bilirubin level ? 1.5 x upper normal limit of the normal range of the laboratory
•Baseline evaluations performed before treatment start: clinical and blood evaluations no more than 2 weeks prior to planned first course; tumoral assessment (CT scan or MRI, X- ray) no more than 4 weeks prior to planned first course
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Response rate (RECIST);Secondary Objective: Overall survival time<br>Safety<br>Progression-free survival time<br>Correlation with EGFR expression<br>;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. <br><br>As secondary endpoints the toxicity profile in combination with Quality of life will be investigated as well as time to progression and overall survival.<br>
- Secondary Outcome Measures
Name Time Method