This trial is active, not recruiting.

Conditions gastric adenocarcinoma, gastroesophageal junction adenocarcinoma
Treatment panitumumab + docetaxel + cisplatino
Phase phase 2
Sponsor Grupo Gallego de Investigaciones Oncologicas
Collaborator Amgen
Start date December 2010
End date December 2014
Trial size 55 participants
Trial identifier NCT01379807, GGIO-2010-01


The clinical hypothesis of this study is that the addition of Panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
panitumumab + docetaxel + cisplatino
Panitumumab, docetaxel and cisplatin combination treatment will be administered for 6 months or until disease progression (PD) according to investigator's criteria unacceptable toxicity or consent withdrawal.

Primary Outcomes

Objective response rate
time frame: 3 years

Secondary Outcomes

Disease control rate
time frame: 3 years
Duration of response
time frame: 3 years
Time to response
time frame: 3 years
Time to progression
time frame: 3 years
Time to treatment failure
time frame: 3 years
Duration of stable disease
time frame: 3 years
Progression free survival
time frame: 3 years
Overall survival
time frame: 3 years
Safety profile
time frame: 3 years
Exploratory Objectives
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Written informed consent Inclusion: - Age ≥ 18 years - Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with advanced unresectable or metastatic disease. - Measurable disease per the revised RECIST (Response Evaluation Criteria in Solid Tumor) Guidelines - ECOG performance score of 0 - 2 - Within seven days prior to initiating study treatment:Haematology:Neutrophils ≥ 1.5x109, Platelets ≥ 100x10/ L, Hemoglobin ≥ 9g/dL. Hepatic functions: Total bilirubin ≤ 1.5 time the upper normal limit (UNL),ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases,ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases. Renal function: creatinine clearance ≥50 mL/min. Metabolic Function: Magnesium ≥ lower limit of normal, Calcium ≥ lower limit of normal. Exclusion Criteria: - Prior chemotherapy or other anticancer therapy for advanced unresectable or metastatic disease (1st line) - Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR inhibitors (e.g. erlotinib). - HER2-positive tumor (centrally assessed) - Past or current history (within the last 5 years prior to treatment start) of other malignancies except gastric cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible) - Current or prior history of central nervous system metastases - Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study - Known hypersensitivity to any of the study drugs - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment - History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. - Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. - Subject (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.

Additional Information

Official title A Phase II Trial to Assess the Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Grupo Gallego de Investigaciones Oncologicas.