Stomach Neoplasms
Conditions
Brief 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.
Interventions
DRUG5-fluorouracil
600 mg/m²/day intravenous
DRUGCisplatin
60 mg/m² or 75 mg/m² intravenous
DRUGDocetaxel
60 mg/m² intravenous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | Throughout the study period |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile | Throughout the study period |
| Overall survival | From beginning to end of study |
| Tumor response | every 8 weeks |
| Clinical toxicities/symptomatology | Throughout the study period |
| Laboratory toxicities/symptomatology | Throughout the study period |
Countries
China
Outcome results
None listed