Taxotere New Indication - Gastric Cancer Treatment Registration Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Drug: 5-fluorouracil
* Drug: Cisplatin
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Administration of docetaxel 60 mg/m² on Day 1, Cisplatin 60 mg/m² after the end of the docetaxel infusion and 5-fluorouracil (5-FU) 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5. | Drug: 5-fluorouracil<br>* 600 mg/m²/day intravenous<br>Drug: Cisplatin<br>* 60 mg/m² or 75 mg/m² intravenous<br>Drug: Docetaxel<br>* 60 mg/m² intravenous<br>|
| Active Comparator: 2<br>Cisplatin 75 mg/m² on Day 1, 5-FU 600 mg/m²/day from Day 1 after the end of the cisplatin infusion to Day 5. | Drug: 5-fluorouracil<br>* 600 mg/m²/day intravenous<br>Drug: Cisplatin<br>* 60 mg/m² or 75 mg/m² intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | Throughout the study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |