Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer

Phase 1

Terminated

Brief Summary: Investigators propose to study the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients with advanced cancer of the stomach.

Detailed Description: Investigators propose a phase I/II study in order to evaluate the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in chemotherapy - naive patients with advanced cancer of the stomach.

Investigators hypothesize that the addition of panitumumab to DCF regimen in advanced cancer of the stomach and gastroesophageal junction is feasible, well tolerated and could achieve an objective response rate of greater than 40%.

The 2-weekly schedule of DCF will be used as chemotherapy since a recently presented trial demonstrated a comparable efficacy but a more favourable toxicity profile comparable to the 3-weekly schedule.

Recruitment & Eligibility

Inclusion Criteria

Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
Patient's age between 20 and 70 years old
Measurable disease defined by RECIST criteria
Patients with non-measurable disease could be enrolled in the phase I part of the study
ECOG performance status ≤ 1
Hgb ≥ 8g/dL, WBC ≥ 3 x 109/L , neutrophils count ≥ 1.5 x 109/L , platelets ≥100 x 109/L, Creatinine clearance ≥50 mL/min, Total bilirubin ≤ 1.5 X UNL, AST, ALT and ALP ≤ 2.5 x UNL
No prior chemotherapy or more than 6 months from adjuvant chemotherapy or chemo-radiation
Estimated life expectancy more than 3 months
Written informed consent

Exclusion Criteria

Gastrointestinal bleeding
Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
CNS metastases
History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds
Any previous chemotherapy or radiotherapy for advanced disease
Patient pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
Patient (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
Known hypersensitivity reaction to the component of the treatment
Active infection or malnutrition or bowel obstruction
Legal incapacity or limited legal capacity
Definite contraindications for the use of corticosteroids
History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
Chronic inflammation of the bowel
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
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
A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer

Arm && Interventions

Group	Intervention	Description
1	Pazopanib	Panitumumab plus DCF

Primary Outcome Measures

Name	Time	Method
Objective response rate	Every 8 weeks	Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression

Secondary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose of the combination	Up to 4 weeks	Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks)
Progression Free Survival	1 year	Patients will be evaluated from the date of the first chemotherapy cycle until the date of first documented progression or date of death from any cause, whichever came first
Overall Survival	1 year	Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause

Locations (9): 401 Military Hospital of Athens
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Athens, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
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Thessaloniki, Greece
"IASO" General Hospital of Athens
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Athens, Greece
State General Hospital of Larissa
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Larissa, Greece
Air Forces Military Hospital of Athens
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Athens, Greece
"Ag.Georgios" General Hospital of Chania
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Chania, Greece
Diabalkaniko General Hospital of Thessaloniki
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Thessaloniki, Greece
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
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Heraklion, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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Piraeus, Greece