Multicenter phase II study of panitumumab, docetaxel, 5-FU, leucovorin and oxaliplatin (P-FLOT) in patients with metastatic or locally advanced Kras wild type adenocarcinoma of the stomach or the gastroesophageal junctio

• Conditions: Adenocarcinoma of the stomach or the gastroesophageal junction; MedDRA version: 14.1Level: LLTClassification code 10017768Term: Gastric cancer stage IV without metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10017767Term: Gastric cancer stage IV with metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-018993-20-DE
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-16
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction with either
-distant metastases (TX NX M1) or
-locally advanced disease (T3/4 N0 M0) or
-stage II / III (> T1 N2 / T2a/b N1)
•No preceding cytotoxic or targeted therapy (adjuvant treatment allowed if finished = 6 months before inclusion)
•Patients with confirmed KRAS wildtype
•At least one unidimensional, measurable tumour parameter according to RECIST
•Age = 18 years
•ECOG = 2
•Adequate haematological, hepatic, renal and metabolic function parameters:
Leukocytes > 3000/mm³, ANC = 1500/mm3, platelets = 100,000/mm3, Hb > 9g/dl (may be transfused or treated with erythropoietin to maintain or exceed this level)
Serum creatinine = 1.5 x upper limit of normal
Bilirubin = upper limit of normal, ASAT and ALAT = 2.5 x upper limit of normal. AP = 2,5 upper limit of normal
Magnesium = lower limit of normal; calcium = lower limit of normal
•Written and signed patient consent form

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

•Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, docetaxel, panitumumab
•Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment.
•History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
•Known brain metastases
•Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
•Other severe internal disease (e.g. insufficiently treated arterial hypertension, other uncontrolled severe disease)
•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 (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
•Peripheral polyneuropathy > NCI Grade I
•Chronic inflammatory bowel disease
•On-treatment participation in a clinical study in the period 30 days prior to inclusion
•Known her2 neu overexpression defined as either Her2 3+ in immunohistochemistry or 2+ in immunohistochemistry and FISH positivity.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: objective remission rate ;Secondary Objective: •Determination of progression-free survival<br>•Time to progression<br>•Overall survival <br>•Adverse events / toxicity<br>•Evaluation of prognostic factors (EGFR signaling, PTEN loss, pharmacogenetics, molecular biology)<br>;Primary end point(s): objective remission rate