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

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.

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 Overview

• Status: Terminated
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Pazopanib

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Panitumumab plus DCF	Drug: Pazopanib; Other Names: Pazopanib: 800mg once a day for up to 2 years from date of first dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	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	1 year
Overall Survival	Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause	1 year
Maximum Tolerated Dose of the combination	Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks)	Up to 4 weeks

Collaborators and Investigators

• Sponsor: Hellenic Oncology Research Group

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 2, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: DCF; Advanced cancer of the stomach; Chemotherapy - naive patients
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: CT/09.10