Open Label, Randomized Multicenter Study Docetaxel + 5-fluorouracil + Cisplatin Compared to Cisplatin + 5-fluorouracil in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Inclusion Criteria:
- Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction,
histologically proven.
- Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the
only manifestation of the disease, cytology or histology is mandatory. Locally
recurrent disease is accepted provided that there is at least one measurable lesion.
- Performance status Karnofsky index >70%
- Life expectancy of more than 3 months
- Adequate haematological parameters (Hb≥9g/dl, ANC≥2.0× 109/L, platelets ≥ 100× 109/L)
- Creatinine ≤ 1.25 UNL, serum magnesium should be within the normal value
- Total bilirubin ≤ 1 UNL, AST and ALT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL
- No prior palliative chemotherapy, previous adjuvant chemotherapy is allowed if more
than 12 months has elapsed between the end of adjuvant therapy and first relapse.
- At least 6 weeks from prior radiotherapy and 3 weeks from surgery
- Complete initial work-up within two weeks prior to first infusion for clinical
evaluation and biological work-up. Abdominal CT scan and chest X-rays are mandatory.
Exclusion Criteria:
- Pregnant or lactating women
- Patients with reproductive potential not implementing adequate contraceptive measures
- Other tumor type than adenocarcinoma
- Any prior palliative chemotherapy. Prior adjuvant chemotherapy with a first relapse
within 12 months from the end of adjuvant
- Prior treatment with taxanes. Prior CDDP as adjuvant chemotherapy with cumulative
dose > 300mg/m²
- Previous or current malignancies other than gastric carcinoma, with the exception of
adequately treated in situ carcinoma of the cervix uteri or non melanoma skin cancer
- Patients with known brain or leptomeningeal metastases
- Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria
- Other serious illness or medical conditions:
- unstable cardiac disease despite treatment, myocardial infarction within 6
months prior to study entry
- history of significant neurologic or psychiatric disorders including dementia or
seizures
- active uncontrolled infection
- active disseminated intravascular coagulation
- other serious underlying medical conditions which could impair the ability of
the patient to participate in the study
- Concurrent treatment with corticosteroids except as use for the prophylactic
medication regimen, treatment of acute hypersensitivity reactions or unless chronic
treatment at low doses
- Definite contraindications for the use of corticosteroids
- Hypercalcemia not controlled by bisphosphonates and more than 12mg/100ml
- Liver impairment with AST or ALT more than 1.5UNL associated with alkaline
phosphatase more than 2.5UNL
- Concurrent or within 4 week period administration of any other experimental drugs
- Concurrent treatment with any other anti-cancer therapy
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.