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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: panitumumab + docetaxel + cisplatino

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • La Coruña, Spain, 15009
    • Centro Oncologico de Galicia
  • La Coruña, Spain, 15006
    • Complejo Hospitalario Universitario de A Coruña
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti
  • Ourense, Spain, 32005
    • Complejo Hospitalario Ourense
  • Pontevedra, Spain, 36002
    • Hospital de Pontevedra
  • La Coruña
    • Ferrol, La Coruña, Spain, 15405
      • Hospital Arquitecto Mercide
    • Santiago de Compostela, La Coruña, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS)
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36204
      • Complejo Hospitalario Universitario de Vigo (Xeral Cies)
    • Vigo, Pontevedra, Spain, 36211
      • Policlínica de Vigo S.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: panitumumab + docetaxel + cisplatino	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		3 years
Duration of response		3 years
Progression free survival		3 years
Time to progression		3 years
Disease control rate		3 years
Time to response		3 years
Time to treatment failure		3 years
Duration of stable disease		3 years
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
Exploratory Objectives	To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints.	3 years

Collaborators and Investigators

• Sponsor: Grupo Gallego de Investigaciones Oncologicas
• Collaborators: Amgen; Trial Form Support S.L.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 10, 2015
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Docetaxel; Panitumumab
• Other Study ID Numbers: GGIO-2010-01