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

Primary Purpose

Gastric Cancer

Status
Terminated
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Pazopanib
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Advanced cancer of the stomach, Chemotherapy - naive patients, DCF

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Panitumumab plus DCF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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)

Full Information

First Posted
October 2, 2012
Last Updated
October 7, 2015
Sponsor
Hellenic Oncology Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT01716546
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Not reached the primary endpoint target according to the statistical design
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Oncology Research Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Advanced cancer of the stomach, Chemotherapy - naive patients, DCF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Panitumumab plus DCF
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Other Intervention Name(s)
Pazopanib: 800mg once a day for up to 2 years from date of first dose
Primary Outcome Measure Information:
Title
Objective response rate
Description
Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression
Time Frame
Every 8 weeks
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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
Time Frame
1 year
Title
Overall Survival
Description
Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause
Time Frame
1 year
Title
Maximum Tolerated Dose of the combination
Description
Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks)
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
"IASO" General Hospital of Athens
City
Athens
Country
Greece
Facility Name
401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
"Ag.Georgios" General Hospital of Chania
City
Chania
Country
Greece
Facility Name
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
City
Heraklion
Country
Greece
Facility Name
State General Hospital of Larissa
City
Larissa
Country
Greece
Facility Name
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
City
Piraeus
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece
Facility Name
Diabalkaniko General Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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