Phase II Study of Docetaxel, Oxaliplatin, Capecitabine with Bevacizumab and Trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positivity inPatients with Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT study) - B-DOCT study

Conditions: ocally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction
MedDRA version: 12.1Level: PTClassification code 10063916Term: Metastatic gastric cancer
MedDRA version: 12.1Level: LLTClassification code 10017758Term: Gastric cancer
MedDRA version: 12.1Level: LLTClassification code 10066896Term: HER-2 positive gastric cancer

Registration Number: EUCTR2010-022699-30-NL

Lead Sponsor: ederlands Kanker Instutuut-Antonie van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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 <50 mL/min
7.Neutrophil count <1.5 × 109/L, or platelet count <100 × 109/L
8.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
9.Known dihydropyrimidine dehydrogenase (DPD) deficiency.
10.History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction; poorly controlled hypertension (systolic BP >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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Overall survival, defined as the time from registration to death<br>Response rate defined as the percentage of partial and complete responses<br>Duration of response defined as time from response to first progression<br>Translational research on pharmacogenomic and biological factors that may predict treatment response.;Primary end point(s): Progression free survival

Secondary Outcome Measures

Name	Time	Method

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