Clinical trial NCT01379807: Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Grupo Gallego de Investigaciones Oncologicas
Sponsor class: OTHER
Collaborators: name: Amgen
name: Trial Form Support S.L.
First posted: 2011-06-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: 3 years
Secondary outcomes:
measure: Disease control rate
timeFrame: 3 years
measure: Duration of response
timeFrame: 3 years
measure: Time to response
timeFrame: 3 years
measure: Time to progression
timeFrame: 3 years
measure: Time to treatment failure
timeFrame: 3 years
measure: Duration of stable disease
timeFrame: 3 years
measure: Progression free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Safety profile
timeFrame: 3 years
measure: Exploratory Objectives
timeFrame: 3 years
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Hospital Arquitecto Mercide
state: La Coruña
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS)
state: La Coruña
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo (Xeral Cies)
state: Pontevedra
city: Vigo
country: Spain
facility: Policlínica de Vigo S.A.
state: Pontevedra
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
city: La Coruña
country: Spain
facility: Centro Oncológico de Galícia
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Ourense
country: Spain
facility: Complejo Hospitalario Ourense
city: Pontevedra
country: Spain
facility: Hospital de Pontevedra
Study officials:
References: