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

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Treatments: Cisplatin; Docetaxel

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