Taxotere + Cisplatin in Nasopharyngeal Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00436293
First received: February 16, 2007
Last updated: November 16, 2010
Last verified: November 2010
  Purpose

Primary objective:

To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.

Secondary objective:

To assess tumor control and survival


Condition Intervention Phase
Nasopharyngeal Neoplasms
Drug: Docetaxel
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Concurrent Cisplatin-radiotherapy With or Without Neoadjuvant Chemotherapy Using Taxotere and Cisplatin in Advanced Nasopharyngeal Carcinoma (NPC)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate. [ Time Frame: From administration of drug to end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: From administration of drug to end of study ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: December 2002
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Neo-adjuvant Taxotere followed by cisplatin and radiotherapy
Drug: Docetaxel
75 mg/m²
Active Comparator: 2
Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy
Drug: Cisplatin
75 mg/m²

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • International Union against Cancer stages III and IV newly diagnosed NPC

Exclusion Criteria:

  • Inadequate bone marrow reserve
  • Inadequate renal function
  • Other primary malignancy
  • Evidence of distant metastases

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436293

Locations
Hong Kong
Sanofi-Aventis
Hong Kong, Hong Kong
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Iris Chan Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00436293     History of Changes
Other Study ID Numbers: XRP6976F_6002
Study First Received: February 16, 2007
Last Updated: November 16, 2010
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014