Status:
COMPLETED
Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive
Lead Sponsor:
Fundación para el Progreso de la Oncología en Cantabria
Conditions:
Stage IV Gastric Cancer With Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of the study is assess the efficacy and safety of Trastuzumab in combination with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or metastatic gastric cancer ...
Detailed Description
Gastric cancer worldwide is the second tumor incidence (10%). There are significant geographical differences in Spain with an incidence of 15 cases/100,000 per year. Although the incidence and mortali...
Eligibility Criteria
Inclusion
- Patients be able to grant a written informed consent or oral consent
- Age ≥18 years old
- Patients diagnosed with metastatic gastric or gastro-esophageal junction adenocarcinoma (HER2-positive), unresectable and histologically confirmed Measurable disease, following the new RECIST criteria,
- HER2 positive tumors (primary or metastatic) with overexpression HER2 determinated by IHQ +++ (IHQ3+) o IHQ ++ confirmed by FISH/SISH positive (IHQ2+/FISH+)
- ECOG ≤ 2
- Patients of childbearing potential (\< 12 months from last menstruation), they have to use effective means of contraception
- Life expectancy more than 3 months
- Adequate renal function: calculated creatinine clearance \> 50 mL/min
- Adequate liver function: AST and ALT ≤2.5 x LSN (5 x LSN with liver metastasis), bilirubin 1,5 x LSN. alkaline phosphatase \< 2,5 x LSN (≤ 5 x LSN with liver metastasis o \< 10 x LSN with bone metastases Adequate haematological function: Hb ≥9 g/dl, neutrophils ≥ 1,5 x 109 /l and platelets 100 x 109 /l.
- Normal Left Ventricle Fraction Ejection , LVEF\> 50%
- Every patient should be treated and followed in his / her study site
Exclusion
- Prior chemotherapy treatment for advanced/metastatic disease
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption
- Patients with active gastrointestinal bleeding
- Prior chemotherapeutic treatment for advanced / metastatic disease
- Toxicity as a result of prior therapy (except alopecia)., for example.
- Neurology toxicity grade ≥2NCI-CTCAE
- Patients who received radiotherapy within 4 weeks prior to study treatment.
- Major surgical procedures within 4 weeks prior to treatment without a total surgical recovery.
- Past or current history of other malignancies (within the last 5-2 years prior to treatment start), patients with curatively treated basal cell carcinoma of the skin or in situ carcinoma of the cervix are eligible
- Active and clinically significant cardiovascular disease,
- History or current clinical evidence of brain metastasis
- Patients undergoing transplantation allogenic requiring immunosuppressive treatment
- Moderate or severe renal failure, creatinine clearance \< 50 mL/min, calculated by Cockcroft-Gault
- Adequate liver function: bilirubin ≤1.5 x UL, GOT ( ASAT )/ GPT ( ALAT ) ≤2,5 LSN. Liver metastasis ≤ 5 x LSN, FA ≤ de 2,5 feces el LSN.
- Adequate haematology function: neutrophils ≥ 1,5 x 109 /l and platelets 100 x 109 /l
- Treatment with sorivudine and the analogous as brivudine.
- Dihydropyrimidine proven dehydrogenase deficiency (DPD).
- Patients who had received any drug, agent or investigational procedure, or who have participated in another research study within 30 days prior to initiation of treatment with study medication.
- Hypersensitivity to any of the study drugs
- 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
- Patients receiving chronic corticosteroid therapy or high dose (is allowed to use inhaled steroids and cycle short treatment with oral steroids for prevention of emesis or to stimulate appetite)
- Pregnancy and lactation
- Patients of childbearing potential not willing to use effective means of contraception.
- History of psychiatric disorders that the investigator considered clinically significant, causing the patient give informed consent or interfere with compliance with study procedures.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01503983
Start Date
August 1 2011
End Date
May 1 2015
Last Update
August 27 2015
Active Locations (13)
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1
Hospital Juan Canalejo
A Coruña, A Coruña, Spain, 15006
2
Centro Oncológico de Galicia
A Coruña, A Coruña, Spain, 15009
3
Hospital Lucus Augusti de Lugo
Lugo, A Coruña, Spain, 27003
4
Hospital de Basurto
Bilbao, Bilbao, Spain, 48013