Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Advanced cancer of the stomach, Chemotherapy - naive patients, DCF
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pazopanib
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 20 Years
Gender: Both
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
Locations
"IASO" General Hospital of Athens
Athens, Greece
Status: Recruiting
Contact: Stylianos Giassas, MD
401 Military Hospital of Athens
Athens, Greece
Status: Recruiting
Contact: Charalampos Christofyllakis, MD - christofyll@yahoo.gr
Air Forces Military Hospital of Athens
Athens, Greece
Status: Recruiting
Contact: Nikos Fytrakis, MD - nikos251@yahoo.gr
"Ag.Georgios" General Hospital of Chania
Chania, Greece
Status: Recruiting
Contact: Panagiotis Koliou, MD - +306973375489 - p_koliou@hotmail.com
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
Heraklion, Greece
Status: Recruiting
Contact: Marina Maurogianni - +302810392091 - marina.st.nurse@gmail.com
State General Hospital of Larissa
Larissa, Greece
Status: Recruiting
Contact: Athanasios Athanasiadis, MD - +306944521400 - athanasiadis.athanasios@gmail.com
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
Status: Recruiting
Contact: Alexandra Karadima, MD - +306975206026
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Status: Recruiting
Contact: Ioannis Mpoukovinas, MD - ibouk@otenet.gr
Diabalkaniko General Hospital of Thessaloniki
Thessaloniki, Greece
Status: Recruiting
Contact: Maria Mperedimou - +302310400489
Start Date
July 2011
Completion Date
July 2014
Sponsors
Hellenic Oncology Research Group
Source
Hellenic Oncology Research Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page