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

Gastric Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01716546
• Other study ID #: CT/09.10
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: October 2, 2012
• Last updated: October 7, 2015
• Start date: July 2011
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Pazopanib

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes