Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer

Stomach Neoplasm Clinical Trial

Official title:

Open Label, Randomized Multicentre Phase II/III Study of Docetaxel in Combination With Cisplatin (CDDP) or Docetaxel in Combination With 5-Fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU 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: NCT00290966
• Other study ID #: EFC6044
• Secondary ID: XRP6976E-325
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 9, 2006
• Last updated: April 28, 2009
• Start date: October 1998
• Est. completion date: May 2003

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Phase II:

Primary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III survival comparison against the CDDP + 5-FU control arm.

Secondary objective: to evaluate the quantitative and qualitative safety profile of the 2 test groups.

Phase III:

Primary objective: to detect a statistically significant increase in time to progression (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).

Main secondary objective: to detect a statistically significant increase in overall survival (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).

Other secondary objectives: to compare response rates, time to treatment failure, duration of response, safety profiles, quality of life and disease-related symptoms.Socio-economic data will be collected in order to be able to perform an analysis by country when necessary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient's consent form obtained, signed and dated before beginning specific protocol procedures.

• 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 (e.g. lymph node).

• Performance status Karnofsky index > 70%.

• Life expectancy of more than 3 months.

• Adequate haematological and biochemistry parameters

• No prior palliative chemotherapy, previous adjuvant (and/or neo-adjuvant) chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant (or neo-adjuvant) therapy and first relapse.

Exclusion Criteria:

• Pregnant or lactating women.

• Patients (M/F) with reproductive potential not implementing adequate contraceptive measures.

• Other tumor type than adenocarcinoma (leiomyosarcoma ; lymphoma).

• Any prior palliative chemotherapy. Prior adjuvant (and/or neo-adjuvant) chemotherapy with a first relapse within 12 months from the end of adjuvant (or neo-adjuvant).

• Prior treatment with taxanes. Prior CDDP as adjuvant (and/or neo-adjuvant) chemotherapy with cumulative dose > 300 mg/m².

Study Design

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

Related Conditions & MeSH terms

• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• XRP6976

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

References & Publications (1)

Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to detect a significant increase in time to progression in favor of docetaxel plus cisplatin and 5-FU compared to cisplatin plus 5-FU. Tumor assessments (assessed with WHO criteria) had to be performed every 8 weeks until progression
Secondary	Patients were to be followed until death (overall survival). Clinical and laboratory were assessed with NCIC-CTG scale, before each cycle. Quality of life and clinical benefit were assessed every 2 weeks until progression and then every 3 months.