Status:
COMPLETED
Taxotere New Indication - Gastric Cancer Treatment Registration Trial
Lead Sponsor:
Sanofi
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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\...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT00811447
Start Date
November 1 2008
End Date
June 1 2012
Last Update
August 31 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Shanghai, China