Clinical trial NCT01716546: Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer
Official title: Phase I/II, Multicenter, Single-Arm Clinical Trial of Panitumumab in Combination With Cisplatin, Fluourouracil and Docetaxel (DCF) in Locally Advanced or Metastatic Cancer of the Stomach and Gastro-oesophageal Junction.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Keywords: Advanced cancer of the stomach
Chemotherapy - naive patients
DCF
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: Every 8 weeks
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
measure: Maximum Tolerated Dose of the combination
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "IASO" General Hospital of Athens
city: Athens
country: Greece
facility: 401 Military Hospital of Athens
city: Athens
country: Greece
facility: Air Forces Military Hospital of Athens
city: Chania
country: Greece
facility: "Ag.Georgios" General Hospital of Chania
city: Heraklion
country: Greece
facility: University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
city: Larissa
country: Greece
facility: State General Hospital of Larissa
city: Piraeus
country: Greece
facility: "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: Diabalkaniko General Hospital of Thessaloniki
Study officials:
References: