Docetaxel in Combination With Cisplatin-5-Fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00565448

Purpose

The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC).

The secondary objectives are to determine:

the safety of TCF in comparison to CF after induction treatment of NPC,
the pharmacokinetics of docetaxel when added to CF,
the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.

Condition	Intervention	Phase
Nasopharyngeal Neoplasms Carcinoma	Drug: docetaxel (XRP6976) Drug: cisplatinum Drug: fluorouracil	Phase II

MedlinePlus related topics: 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:	International Randomized Study to Evaluate the Addition of Docetaxel to the Combination of Cisplatin-5-Fluorouracil (TCF) vs. Cisplatin-5-Fluorouracil (CF) in the Induction Treatment of Nasopharyngeal Carcinoma (NPC) in Children and Adolescents

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Complete response (CR) rate according to the Response Evaluation Criteria in Solid Tumors (RECIST) after the completion of the induction treatment [ Time Frame: after the completion of the induction treatment (3 cycles) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall safety and efficacy of docetaxel in combination with CF [ Time Frame: From first dose through 30 days after last dose of docetaxel ] [ Designated as safety issue: No ]
Pharmacokinetic analysis [ Time Frame: 3 plasma samples just before and after the end of infusion ] [ Designated as safety issue: No ]
Overall response [ Time Frame: on completion of radiotherapy treatment ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TCF: Experimental	Drug: docetaxel (XRP6976) IV route Drug: cisplatinum IV route Drug: fluorouracil IV route
CF: Active Comparator	Drug: cisplatinum IV route Drug: fluorouracil IV route

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
Newly diagnosed disease NPC Stage IIB-IV disease with measurable disease

Exclusion Criteria:

Patients with short life expectancy
Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
Inadequate renal function evidenced by unacceptable laboratory results

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565448

Locations

United States, New Jersey
Sanofi-Aventis Aministrative Office
Bridgewater, New Jersey, United States, 08807
Algeria
Sanofi-Aventis Administrative Office
Alger, Algeria
Brazil
Sanofi-Aventis Aministrative Office
Sao Paulo, Brazil
China
Sanofi-Aventis Administrative Office
Beijing, China
France
Sanofi-Aventis Administrative Office
Paris, France
India
Sanofi-Aventis Aministrative Office
Mumbai, India
Indonesia
Sanofi-Aventis Administrative Office
Jakarta, Indonesia
Italy
Sanofi-Aventis Aministrative Office
Milano, Italy
Korea, Republic of
Sanofi-Aventis Aministrative Office
Seoul, Korea, Republic of
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Morocco
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Philippines
Sanofi-Aventis Administrative Office
Makati City, Philippines
Thailand
Sanofi-Aventis Aministrative Office
Bangkok, Thailand
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia
Turkey
Sanofi-Aventis Aministrative Office
Istanbul, Turkey

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC10339
Study First Received:	November 29, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00565448
Health Authority:	United States: Food and Drug Administration; Hong Kong: Ethics Committee; India: Ministry of Health; Turkey: Ministry of Health

Keywords provided by Sanofi-Aventis:

Nasopharyngeal carcinoma

Study placed in the following topic categories:

Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Carcinoma
Docetaxel

Nasopharyngeal carcinoma
Cisplatin
Head and Neck Neoplasms
Fluorouracil
Stomatognathic Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Nasopharyngeal Diseases

ClinicalTrials.gov processed this record on January 16, 2009