Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Objective response rate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression
- Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause
- Maximum Tolerated Dose of the combination [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks)
|Study Start Date:||July 2011|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Panitumumab plus DCF
Other Name: Pazopanib: 800mg once a day for up to 2 years from date of first dose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716546
|"IASO" General Hospital of Athens|
|401 Military Hospital of Athens|
|Air Forces Military Hospital of Athens|
|"Ag.Georgios" General Hospital of Chania|
|University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece|
|State General Hospital of Larissa|
|"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology|
|"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology|
|Diabalkaniko General Hospital of Thessaloniki|