Efficacy and Safety of Panitumumab Combined With Docetaxel and Cisplatin as a First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Gastric Adenocarcinoma Clinical Trial

— SPIGA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01379807
• Other study ID #: GGIO-2010-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 22, 2011
• Last updated: March 10, 2015
• Start date: December 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2011
• Source: Grupo Gallego de Investigaciones Oncologicas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Arquitecto Mercide	Ferrol	La Coruña
Spain	Centro Oncológico de Galícia	La Coruña
Spain	Complejo Hospitalario Universitario de A Coruña	La Coruña
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Complejo Hospitalario Ourense	Ourense
Spain	Hospital de Pontevedra	Pontevedra
Spain	Complejo Hospitalario Universitario de Santiago (CHUS)	Santiago de Compostela	La Coruña
Spain	Complejo Hospitalario Universitario de Vigo (Xeral Cies)	Vigo	Pontevedra
Spain	Policlínica de Vigo S.A.	Vigo	Pontevedra

Sponsors (3)

Lead Sponsor	Collaborator
Grupo Gallego de Investigaciones Oncologicas	Amgen, Trial Form Support S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	To estimate the objective response rate in patients treated with docetaxel, cisplatin and panitumumab as first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma.	3 years	No
Secondary	Disease control rate		3 years	No
Secondary	Duration of response		3 years	No
Secondary	Time to response		3 years	No
Secondary	Time to progression		3 years	No
Secondary	Time to treatment failure		3 years	No
Secondary	Duration of stable disease		3 years	No
Secondary	Progression free survival		3 years	No
Secondary	Overall survival		3 years	No
Secondary	Safety profile	To describe the safety profile of this combination therapy in the 1st-line setting including the incidence of AE's and changes in laboratory parameters.	3 years	Yes
Secondary	Exploratory Objectives	To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints.	3 years	No