Taxotere New Indication - Gastric Cancer Treatment Registration Trial

NCT00811447 | Completed Phase 3

• 1 other identifier: DOCET_L_02195
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Time to progression

  Throughout the study period

Secondary Outcomes (5)

• 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

Study Arms (2)

1

EXPERIMENTAL

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; Drug: Cisplatin; Drug: Docetaxel

2

ACTIVE COMPARATOR

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; Drug: Cisplatin

Interventions

5-fluorouracil DRUG

600 mg/m²/day intravenous

1; 2

Cisplatin DRUG

60 mg/m² or 75 mg/m² intravenous

1; 2

Docetaxel DRUG

60 mg/m² intravenous

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Shanghai, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Fluorouracil; Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Martin Thoenes

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 31, 2012

Record last verified: 2012-08

Locations

CN (1)