EUCTR2005-000387-39-ESActive, not recruitingPhase 1
An open-label randomized multicentre phase III study of trastuzumab in combination with a fluoropyrimidine and cisplatin versus chemotherapy alone as first-line therapy in patients with HER2 positive advanced gastric cancer.Estudio de fase III multicéntrico, abierto, randomizado de trastuzumab en combinación con una fluoropirimidina y cisplatino, frente a quimioterapia sola, como tratamiento en primera línea de pacientes con cáncer gástrico avanzado HER2 positivo.
Hoffmann-La Roche Ltd/Inc/AG/Roche Global Development0 sites374 target enrollmentStarted: June 13, 2005Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 374
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Disease Specific 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), or non-measurable evaluable disease, assessed using imaging techniques (CT or MRI).
- •3. HER2 positive tumour (primary tumour or metastasis) as assessed by the central laboratory. (Both IHC and FISH will be performed on all patients in the central laboratory.)
- •4. ECOG Performance status 0, 1 or 2.
- •5. Life expectancy of at least 3 months.
- •General Inclusion Criteria:
- •6. Male or female. Age greater or equal to 18 years.
- •7. Signed informed consent.
- •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
- •Cancer-Related 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 platin 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 probe).
- •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 ? grade 2 NCI-CTCAE.
- •5. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
- •Haematological, Biochemical and Organ Function:
- •1. Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L.
- •2. 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.
- •3. Creatinine clearance < 60 mL/min.
- •Other Study Drug-Related Exclusion Criteria:
- •1. 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.
- •2. Baseline LVEF < 50% (measured by echocardiography or MUGA).
- •3. Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
- •4. 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).
- •5. Clinically significant hearing abnormality.
- •6. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •General Exclusion Criteria:
- •1. History or clinical evidence of brain metastases.
- •2. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- •3. Positive serum pregnancy test in women of childbearing potential.
- •4. Subjects with reproductive potential not willing to use an effective method of contraception.
- •5. Received any investigational drug treatment within 4 weeks of start of study treatment.
- •6. 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).
- •7. Major surgery within 4 weeks of start of study treatment, without complete recovery.
- •8. Patients with known active infection with HIV, HBV, or HCV. (Patients with known HIV, HBV or HCV positivity are not allowed to participate in the PK substudy.)
- •9. Known hypersensitivity to any of the study drugs.
Investigators
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