taxotere new indication - gastric cancer treatment registration trial

Conditions: Stomach Neoplasms

Summary: 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.


Eligibility criteria:
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.