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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hellenic Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01716546
First received: October 2, 2012
Last updated: June 21, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: Pazopanib
Phase 1
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 108
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Panitumumab plus DCF
Drug: Pazopanib
Other Name: Pazopanib: 800mg once a day for up to 2 years from date of first dose

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716546

Contacts
Contact: Sofia Aggelaki, MD +302810392747 agelaki@med.uoc.gr
Contact: Dora Chatzidaki +302810392570 dorachat@med.uoc.gr

Locations
Greece
"IASO" General Hospital of Athens Recruiting
Athens, Greece
Contact: Stylianos Giassas, MD         
Principal Investigator: Stylianos Giassas, MD         
401 Military Hospital of Athens Recruiting
Athens, Greece
Contact: Charalampos Christofyllakis, MD       christofyll@yahoo.gr   
Principal Investigator: Charalampos Christofyllakis, MD         
Air Forces Military Hospital of Athens Recruiting
Athens, Greece
Contact: Nikos Fytrakis, MD       nikos251@yahoo.gr   
Principal Investigator: Nikos Kentepozidis, MD         
Sub-Investigator: Nikos Fytrakis, MD         
"Ag.Georgios" General Hospital of Chania Recruiting
Chania, Greece
Contact: Panagiotis Koliou, MD    +306973375489    p_koliou@hotmail.com   
Principal Investigator: Ioannis Varthalitis, MD         
Sub-Investigator: Panagiotis Koliou, MD         
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece Recruiting
Heraklion, Greece
Contact: Marina Maurogianni    +302810392091    marina.st.nurse@gmail.com   
Principal Investigator: Vassilis Georgoulias, MD         
State General Hospital of Larissa Recruiting
Larissa, Greece
Contact: Athanasios Athanasiadis, MD    +306944521400    athanasiadis.athanasios@gmail.com   
Principal Investigator: Athanasios Athanasiadis, MD         
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology Recruiting
Piraeus, Greece
Contact: Alexandra Karadima, MD    +306975206026      
Principal Investigator: Nikolaos Ziras, MD         
Sub-Investigator: Alexandra Karadima, MD         
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Recruiting
Thessaloniki, Greece
Contact: Ioannis Mpoukovinas, MD       ibouk@otenet.gr   
Principal Investigator: Ioannis Mpoukovinas, MD         
Diabalkaniko General Hospital of Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Maria Mperedimou    +302310400489      
Principal Investigator: Christos Emmanouilidis, MD         
Sponsors and Collaborators
Hellenic Oncology Research Group
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT01716546     History of Changes
Other Study ID Numbers: CT/09.10
Study First Received: October 2, 2012
Last Updated: June 21, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Advanced cancer of the stomach
Chemotherapy - naive patients
DCF

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on November 20, 2014