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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00290966

Purpose

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.

Condition	Intervention	Phase
Stomach Neoplasm	Drug: docetaxel	Phase II Phase III

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Docetaxel Cisplatin Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	610
Study Start Date:	October 1998
Estimated Study Completion Date:	May 2003

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290966

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:	Jaffer Ajani, MD	MD Anderson Cancer Center, Houston, Texas, US
Principal Investigator:	E. Van Cutsem, MD	University hospital Gasthuisberg, Leuven, Belgium

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

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 first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006 Nov 1;24(31):4991-7.

Study ID Numbers:	EFC6044 / XRP6976E-325, XRP6976E-325
Study First Received:	February 9, 2006
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00290966
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency

Keywords provided by Sanofi-Aventis:

docetaxel
stomach neoplasm

Study placed in the following topic categories:

Docetaxel
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Gastrointestinal Diseases

Fluorouracil
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009