Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00772681

Purpose

To assess the efficacy of docetaxel, cisplatin combination in terms of disease free survival.
Time to progression of the disease in terms of local and distant failure; assess the survival time, and assess the objective (clinical and radiological) response rate and the safety of the treatment.

Condition	Intervention	Phase
Head and Neck Neoplasms	Drug: docetaxel and cisplatin	Phase IV

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Docetaxel Cisplatin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase IV Clinical Study Evaluating The Efficacy of Chemoradiotherapy Following Neoadjuvant Treatment With Docetaxel and Cisplatin in Indifferentiated and Non-Keratinized Squamous Cell Carcinoma of Nasopharynx

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Efficacy by disease free survival [ Time Frame: After neoadjuvant treatment and during the follow up period (2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy by time to progression of the disease in terms of local and distant failure; [ Time Frame: Until Progression ] [ Designated as safety issue: No ]
Efficacy by the survival time [ Time Frame: 2 years after the end of treatment ] [ Designated as safety issue: No ]
The objective (clinical and radiological) response rate [ Time Frame: 2 years after the treatment ] [ Designated as safety issue: No ]
The safety of the treatment. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment:	57
Study Start Date:	October 2004
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: docetaxel and cisplatin 3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks

Eligibility

Criteria

Inclusion Criteria:

Histologically/cytologically confirmed, patients with stage T2b-T4N1 or TanyN2-3 undifferentiated or nonkeratinized squamous cell carcinoma of nasopharynx who are candidate for curative radiotherapy.
ECOG Performance Status is 0-1
Weight loss within last 6 months <10% of body weight
Acceptable haematological profile (as defined by a leukocyte count ≥ 4000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)

Exclusion Criteria:

Patients with stage IVC or metastatic disease
Patients treated with chemotherapy for nasopharyngeal cancer
Patients treated with radiotherapy to head and neck region
Concomitant use of another anti-cancer therapy
Patients treated with amifostine or pilocarpine during protocol treatment.
Unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 6 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection.
Presence of other tumours different from carcinoma of the skin except melanoma and carcinoma in situ of the breast and cervix with disease free survival less than 5 years.
Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
Social or psychological condition that render the patient inadequate for the follow-up of the study
Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)

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: NCT00772681

Locations

Turkey
Sanofi aventis administrative office
Istanbul, Turkey

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Edibe Taylan, MD

Sanofi-Aventis

More Information

Responsible Party:	Sanofi aventis ( Medical Affairs Study Director )
Study ID Numbers:	XRP6976F_6007
Study First Received:	October 13, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00772681
Health Authority:	Turkey: Ethics Committee

Study placed in the following topic categories:

Docetaxel
Epidermoid carcinoma
Nasopharyngeal carcinoma
Cisplatin
Squamous cell carcinoma

Head and Neck Neoplasms
Carcinoma, squamous cell
Carcinoma, Squamous Cell
Carcinoma

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 14, 2009