Trastuzumab in Combination With Capecitabine and Oxaliplatin(XELOX) in Patients With Advanced Gastric Cancer(AGC): Her+XELOX

NCT01396707 | Completed Phase 2

• 1 other identifier: AMC1101
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multicentre, prospective phase II trial designed to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction.

Conditions

Metastatic or Recurrent Gastric Adenocarcinoma; Her-2 Positive Gastric Cancer

Keywords

HER2; Trastuzumab; XELOX; PHASE 2

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  To evaluate the overall response rate for patients treated with trastuzumab combinated with capecitabine plus oxaliplatin.

  1 year

Secondary Outcomes (4)

• Duration of response

  1 year

• Time to progression

  1 year

• Progression free survival

  1 year

• Overall survival

  1 year

Study Arms (1)

Herceptin+XELOX

EXPERIMENTAL

Drug: Herceptin+XELOX

Interventions

Herceptin+XELOX DRUG

Each 3-weekly cycle, with chemotherapy given for 6 cycles, and trastuzumab continued even after completion of the combination chemotherapy until disease progression * Trastuzumab: 8 mg/kg i.v. loading dose on day 1, followed by 6 mg/kg i.v.infusion every 3 weeks * Capecitabine: 1000 mg/m2 oral twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15) * Oxaliplatin 130 mg/m2 i.v. on day 1

Also known as: Trastuzumab, Capecitabine, Oxaliplatin

Herceptin+XELOX

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
• Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), assessed using imaging techniques (CT or MRI).
• HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2
• ECOG Performance status 0, 1 or 2
• Life expectancy of at least 3 months.
• Male or female. Age over 20 year.
• Signed informed consent.

You may not qualify if:

• Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platinum is not allowed).
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy tube).
• Patients with active (significant or uncontrolled) gastrointestinal bleeding.
• Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity over grade 2 NCI-CTCAE.
• Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
• Neutrophil count \< 1.5 × 109/L, or platelet count \< 100 × 109/L.
• Serum bilirubin \> 1.5 × upper limit of normal (ULN); or, AST or ALT \> 2.5 × ULN (or \> 5 × ULN in patients with liver metastases); or, alkaline phosphatase \> 2.5 × ULN (or \> 5 × ULN in patients with liver metastases, or \> 10 × ULN in patients with bone but no liver metastases); or, albumin \< 25 g/L.
• History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
• Baseline LVEF \< 50% (measured by echocardiography or MUGA).
• Patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
• Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
• Clinically significant hearing abnormality.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.
• History or clinical evidence of brain metastases.
• Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.

Sponsors & Collaborators

• Asan Medical Center: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

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MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Trastuzumab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Yoon-Koo Kang, MD, PhD

  Asan Medical Center

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2018
• Study Completion: March 1, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

KR (1)