Taxotere New Indication - Gastric Cancer Treatment Registration Trial

Phase 3

Completed

• Conditions: Stomach Neoplasms
• Interventions: Drug: 5-fluorouracil; Drug: Cisplatin; Drug: Docetaxel

• Registration Number: NCT00811447
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-18
• Study First Posted: 2008-12-19
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-30
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	5-fluorouracil	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.
2	Cisplatin	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.
1	Cisplatin	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.
1	Docetaxel	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.
2	5-fluorouracil	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.

Primary Outcome Measures

Name	Time	Method
Time to progression	Throughout the study period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇳 Shanghai, China