Taxotere New Indication - Gastric Cancer Treatment Registration Trial

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

Primary objective:

To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® [Docetaxel] combined with cisplatin and 5-fluorouracil [TCF]) relative to the control group (Cisplatin combined with 5-fluorouracil[CF])

Secondary objectives:

• To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group.
• To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.

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.