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

NCT01503983 | Completed Phase 2 DMC

• 2 other identifiers: FUPOCAN-01-112011-001231-23
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 13

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

Conditions

Stage IV Gastric Cancer With Metastasis

Keywords

Gastric Cancer with Metastasis; HER2-positive

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival defined as the time from start of treatment until the patient's death

  up to 10 Months

Secondary Outcomes (4)

• progression free survival

  5 months

• the time to progression

  5 months

• duration of response

  10 months

• time to response

  10 months

Study Arms (1)

Trastuzumab+Oxaliplatine+capecitabine

EXPERIMENTAL

Patient takes Trastuzumab (initial dose 8 mg/kg and a maintenance dose 6 mg/kg) anda oxaliplatin (dose 130mg/m2) during the first day os cycle and them Capecitabine (dose 2000 mg/m2)during 14 days in cycle of 21 days.

Drug: Trastuzumab; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Trastuzumab DRUG

Trastuzumab: 8 mg/kg day 1 followed by 6 mg/kg every 3 weeks (i.v.)

Also known as: Herceptin

Trastuzumab+Oxaliplatine+capecitabine

Capecitabine DRUG

Capecitabine: 1000 mg/m2/12h/days 1 - 14 every 3 weeks (v.o.)

Also known as: Xeloda

Trastuzumab+Oxaliplatine+capecitabine

Oxaliplatin DRUG

Oxaliplatin: 130 mg/m2 in 2 h, day 1 / (i.v.) /every 3 weeks

Also known as: Oxaliplatino

Trastuzumab+Oxaliplatine+capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación para el Progreso de la Oncología en Cantabria: lead

Study Sites (13)

Hospital Juan Canalejo

A Coruña, A Coruña, 15006, Spain

Location

Centro Oncológico de Galicia

A Coruña, A Coruña, 15009, Spain

Location

Hospital Lucus Augusti de Lugo

Lugo, A Coruña, 27003, Spain

Location

Hospital de Basurto

Bilbao, Bilbao, 48013, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Arnau de Vilanova de LLeida

Lleida, Lleida, 25198, Spain

Location

Hospital Gregorio Marañon

Madrid, Madrid, 28009, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital de Orense

Ourense, Orense, 32005, Spain

Location

Hospital Universitario Cnetral de Asturias

Oviedo, Oviedo, 33006, Spain

Location

Hospital Provincial de Pontevedra

Pontevedra, Vigo, 36001, Spain

Location

Hospital Xeral Cies

Vigo, Vigo, 36204, Spain

Location

Hospital de POVISA

Vigo, Vigo, 36211, Spain

Location

MeSH Terms

Interventions

Trastuzumab; Capecitabine; Oxaliplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Fernando Rivera NA, Doctor

  Sponsor represntative

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: January 4, 2012
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2012-04

Locations

ES (13)