First Line Dose-Dense Chemotherapy With Docetaxel, Cisplatin, Folinic Acid and 5- Fluorouracil plus Panitumumab in Patients With Locally Advanced or Metastatic Cancer of the Stomach or Gastro-Esophageal Junction: A Phase II Multicentre Trial - GOIRC 02/2009

Phase 1

• Conditions: Patients with metastatic or locally advanced not resectable cancer of the stomach or gastro-esophageal junction.; MedDRA version: 9.1Level: PTClassification code 10017758; MedDRA version: 9.1Level: HLTClassification code 10030176

• Registration Number: EUCTR2009-016962-10-IT
• Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-19
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Histologically confirmed advanced carcinoma of the stomach or oesophago-gastric junction 2. Patients with locally advanced inoperable tumors 3. Measurable lesions according to RECIST criteria (version 1.1) 4. A previous adjuvant chemotherapy for gastric cancer is authorized provided that it was finished minimum 6 months before the inclusion in this protocol and if the patient is considered free from adverse events related to adjuvant chemotherapy. 5. Age ≥ 18, and ≤ 75 years 6. ECOG Performance status 0-1 7. Hematological examination : Neutrophilic count ≥ 1.5 X 109 / l, Platelets ≥ 100 X 109 /l, Hemoglobin ≥ 10 g / dl ASAT/ALAT ≤ 1,5 X ULN , Alkaline Phosphatases < 2,5 ULN Bilirubin ≤ 1,5 X ULN Clearance creatinine ≥ 60 ml/min Magnesium ≥ lower limit of normal. Calcium ≥ lower limit of normal 8. Written informed consen
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

1. Uncontrolled central nervous system metastases. 2. Past (less than 10 years) or current history of malignant neoplasms, except for curatively treated carcinoma in situ of the cervix or basal and squamous cell carcinoma of the skin. 3. Participation to another clinical study within 4 weeks before inclusion in this study 4. Concomitant antineoplastic treatment. 5. Previous use in adjuvant setting of more than 400 mg/m? (total cumulated dose) cisplatin 6. Known deficiency in DPD or allergy to one or more drugs of the study 7. Uncontrolled angina pectoris or myocardial infarction < 6 weeks before beginning of the chemotherapy 8. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)  1 year before enrollment/randomization 9. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. 10. Other concurrent serious diseases that may interfere with planned treatment. 11. Uncontrolled infectious disease. 12. Impossibility to assure an adequate follow-up due to psychological, familial, social and/or geographic reasons. 13. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the antitumour activity of Panitumumab in combination with a dose-dense chemotherapy regimen;Secondary Objective: To evaluate the safety of the combination;Primary end point(s): Overall response rate (complete and partial responses).