- ICH GCP
- US Clinical Trials Registry
- 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 (SPIGA)
March 10, 2015 updated by: Grupo Gallego de Investigaciones Oncologicas
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
55
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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La Coruña, Spain, 15009
- Centro Oncológico de Galicia
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La Coruña, Spain, 15006
- Complejo Hospitalario Universitario de A Coruna
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Lugo, Spain, 27003
- Hospital Universitario Lucus Augusti
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Ourense, Spain, 32005
- Complejo Hospitalario Ourense
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Pontevedra, Spain, 36002
- Hospital de Pontevedra
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La Coruña
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Ferrol, La Coruña, Spain, 15405
- Hospital Arquitecto Mercide
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Santiago de Compostela, La Coruña, Spain, 15706
- Complejo Hospitalario Universitario de Santiago (CHUS)
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Pontevedra
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Vigo, Pontevedra, Spain, 36204
- Complejo Hospitalario Universitario de Vigo (Xeral Cies)
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Vigo, Pontevedra, Spain, 36211
- Policlínica de Vigo S.A.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: panitumumab + docetaxel + cisplatino
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: 3 years
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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.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 3 years
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3 years
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Duration of response
Time Frame: 3 years
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3 years
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Progression free survival
Time Frame: 3 years
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3 years
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Time to progression
Time Frame: 3 years
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3 years
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Disease control rate
Time Frame: 3 years
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3 years
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Time to response
Time Frame: 3 years
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3 years
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Time to treatment failure
Time Frame: 3 years
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3 years
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Duration of stable disease
Time Frame: 3 years
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3 years
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Safety profile
Time Frame: 3 years
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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.
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3 years
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Exploratory Objectives
Time Frame: 3 years
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To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints.
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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