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

NCT ID: NCT01379807

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

panitumumab + docetaxel + cisplatino

Group Type: EXPERIMENTAL

panitumumab + docetaxel + cisplatino

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Trial Form Support S.L.

OTHER

Sponsor Role: collaborator

Grupo Gallego de Investigaciones Oncologicas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Complejo Hospitalario Universitario de A Coruña

A Coruña, La Coruña, Spain

Centro Oncológico de Galícia

A Coruña, La Coruña, Spain

Hospital Arquitecto Mercide

Ferrol, La Coruña, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, La Coruña, Spain

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

Complejo Hospitalario Ourense

Ourense, Ourense, Spain

Hospital de Pontevedra

Pontevedra, Pontevedra, Spain

Complejo Hospitalario Universitario de Vigo (Xeral Cies)

Vigo, Pontevedra, Spain

Policlínica de Vigo S.A.

Vigo, Pontevedra, Spain

Countries

Spain

Other Identifiers

GGIO-2010-01

Identifier Type: -

Identifier Source: org_study_id