Multi-centre, phase II, single arm study of the docetaxel, oxaliplatin, capecitabine (DOC) combination in untreated patients with advanced or metastatic gastric cancer

• Conditions: patients with metastatic gastric carcinoma; MedDRA version: 14.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001720-37-IT
• Lead Sponsor: CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-27
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Age =18, - Histologically or cytologically confirmed adenocarcinoma of the stomach or lower third of the oesophagus, - HER2/NEU status as negative (IHC 1-2+; FISH negative). - Clinical stage: T4 N-/+ M0 or TxNxM1; local relapse not amenable to curative surgery. - The stage classification is clinical and will be defined by the most appropriate method (Physical exam, EGDS, EUS, CT, MRI). - ECOG Performance Status of 0 or 1. - Royal Marsden Hospital prognostic index, Group 1(See appendix). - No previous chemotherapy for advanced or locally relpsed disease. - Previous adjuvant chemotherapy completed at least 6 months before registration. - Measurable/evaluable disease, according to the (NCI-CTCAE v.3) criteria. - Baseline laboratory values: absolute neutrophil count (ANC) =2000/mm3, hemoglobin >10.0 g/dL, platelet count =100,000/mm3??creatinine <1.5 times the upper limit of normal (ULN); in case of threshold values the creatinine clearance will be evaluated according to the Cockroft-Gault formula and should be > 60 ml/min, transaminases <2.5 times ULN, alkaline phosphatase < 2.5 times ULN, total bilirubin < 1.0 times ULN. -Signed written informed consent. -Patient willing and able to comply with protocol requirements. -Life expectancy > 3 months. -Recovery from acute effects of surgery.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

- HER2+ positivity (immunohistochemistry 3+ or fluorescence in situ hybridization–amplified). -Previous chemotherapy for metastatic or relapsed disease. -New York Heart Association Class 3 or 4 heart disease. -Clinically significant heart disease, including but not limited to: myocardial infarction within the last 6 months, congestive heart failure, unstable angina, clinically significant pericardial effusion or serious arrhythmia. -Peripheral neuropathy grade = 2 according to the NCI-CTCAE v.3. -Any serious active infection (uncontrolled or requiring treatment). -Any history or evidence of CNS disease, e.g. brain metastases. -Any known hypersensitivity to study drug components. -Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. -Pregnant or lactating women. -Fertile patients (male and female) unwilling to use effective means of contraception during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified