Taxotere New Indication - Gastric Cancer Treatment Registration Trial

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811447
• Other study ID #: DOCET_L_02195
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2008
• Last updated: August 30, 2012
• Start date: November 2008
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• 5-fluorouracil
600 mg/m²/day intravenous
• Cisplatin
60 mg/m² or 75 mg/m² intravenous
• Docetaxel
60 mg/m² intravenous

Locations

Country	Name	City	State
China	Sanofi-Aventis Administrative Office	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression		Throughout the study period	No
Secondary	Safety profile		Throughout the study period	No
Secondary	Overall survival		From beginning to end of study	No
Secondary	Tumor response		every 8 weeks	No
Secondary	Clinical toxicities/symptomatology		Throughout the study period	No
Secondary	Laboratory toxicities/symptomatology		Throughout the study period	No