Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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 or gastro-esophageal junction, (HER2)-positive.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación para el Progreso de la Oncología en Cantabria
• Treatments: Capecitabine; Oxaliplatin; Trastuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.