Her-2 Positive Gastric Cancer, Metastatic or Recurrent Gastric Adenocarcinoma
Conditions
Keywords
HER2, Trastuzumab, XELOX, PHASE 2
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.
Detailed description
Patients will be administered 6 cycles of combination chemotherapy, unless withdrawn earlier due to unacceptable toxicity, disease progression, or consent withdrawal. Patients will continue to be treated with trastuzumab alone until disease progression, unacceptable toxicity or consent withdrawal after finishing a maximum 6 cycles of combination chemotherapy.
Interventions
DRUGHerceptin+XELOX
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
Sponsors
Hoffmann-La Roche
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), assessed using imaging techniques (CT or MRI). 3. HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2 4. ECOG Performance status 0, 1 or 2 5. Life expectancy of at least 3 months. 6. Male or female. Age over 20 year. 7. Signed informed consent.
Exclusion criteria
1. 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). 2. 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). 3. Patients with active (significant or uncontrolled) gastrointestinal bleeding. 4. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity over grade 2 NCI-CTCAE. 5. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. 6. Neutrophil count \< 1.5 × 109/L, or platelet count \< 100 × 109/L. 7. 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. 8. Creatinine clearance \< 60 mL/min. Other Study Drug-Related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 1 year | To evaluate the overall response rate for patients treated with trastuzumab combinated with capecitabine plus oxaliplatin. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response | 1 year |
| Time to progression | 1 year |
| Progression free survival | 1 year |
| Overall survival | 1 year |
Countries
South Korea
Outcome results
None listed