Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction MedDRA version: 12.1 Level: PT Classification code 10063916 Term: Metastatic gastric cancer MedDRA version: 12.1 Level: LLT Classification code 10017758 Term: Gastric cancer MedDRA version: 12.1 Level: LLT Classification code 10066896 Term: HER-2 positive gastric cancer
Conditions
Sponsors
Nederlands Kanker Instutuut-Antonie van Leeuwenhoek Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
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 Tumours (RECIST), assessed using imaging techniques (CT or MRI) 3. ECOG Performance status 0, 1 or 2 4. Life expectancy of at least 3 months 5. Male or female age = 18 years 6. Signed informed consent 7. Assessment of HER2 status (primary tumour or metastasis) by the central laboratory prior to initiation of study treatment (Dual SISH, Ventana). 8. Able to swallow and retain oral medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy for advanced/metastatic disease (prior peri-operative chemotherapy is allowed if at least 6 months has elapsed between completion of this therapy and enrolment into the study) 2. Previous radiotherapy on the abdomen 3. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma 4. Patients with active (significant or uncontrolled) gastrointestinal bleeding 5. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity = grade 2 NCI-CTCAE 6. Creatinin clearance 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 180 mmHg or diastolic BP >100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias. 11. Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy. 12. 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) 13. Major surgery within 4 weeks of start of study treatment, 14. Known hypersensitivity to any of the study drugs 15. History or clinical evidence of brain metastases 16. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes 17. Positive serum pregnancy test in women with childbearing potential 18. Subjects with reproductive potential not willing to use an effective method of contraception 19. Any investigational drug treatment within 4 weeks of start of study treatment 20. Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastastic site peripherally and patient recovered from any acute toxicity) 21. Therapeutic use of oral coumarin-derived or LMWH anticoagulants or NSAIDs. 22. Continuous use of immunosuppressive agents (for the use of corticosteroids see #12).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect on progression free survival defined as the time measured from the day of registration to first progression or death.;Secondary Objective: Toxicity Overall survival, defined as the time from registration to death Response rate defined as the percentage of partial and complete responses Duration of response defined as time from response to first progression Translational research on pharmacogenomic and biological factors that may predict treatment response.;Primary end point(s): Progression free survival | — |
Countries
Netherlands
Outcome results
None listed