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Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nasopharyngeal Neoplasms; Carcinoma

Intervention: docetaxel (Drug); cisplatin (Drug); 5-fluorouracil (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi


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.

Clinical Details

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

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

Primary outcome: Number of Participants With Complete Response (CR)

Secondary outcome:

Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group

Overall Response (OR)

Overall Survival (OS) Rate

Detailed description: Planned treatment duration:

- induction period: 9 weeks of induction treatment

- consolidation period: 9 weeks of chemoradiation treatment.

The consolidation treatment was the same for all participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.


Minimum age: 1 Month. Maximum age: 21 Years. Gender(s): Both.


Inclusion Criteria:

- Histological diagnosis of nasopharyngeal carcinoma World Health Organization (WHO)

type II or III

- Children and adolescents newly diagnosed with Stage IIB-IV NPC with measurable

disease, who are >1 month to ≤21 years of age at the time of diagnosis. In France, participants must be ≥1 year to ≤21 years of age at the time of diagnosis Exclusion Criteria:

- Participants 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 participant's potential participation in a clinical trial.

Locations and Contacts

Investigational Site Number 012001, Alger 16005, Algeria

Investigational Site Number 076002, Rio De Janeiro 20230-130, Brazil

Investigational Site Number 076001, Sao Paulo 04023-062, Brazil

Investigational Site Number 156005, Fuzhou 350014, China

Investigational Site Number 250001, Villejuif Cedex 94805, France

Investigational Site Number 356003, Ahmedabad 380006, India

Investigational Site Number 356004, Kolkata 700054, India

Investigational Site Number 356002, Thiruvananthapuram 695011, India

Investigational Site Number 356001, Vellore 632004, India

Investigational Site Number 360001, Jakarta 10430, Indonesia

Investigational Site Number 380001, Milano 20133, Italy

Investigational Site Number 410001, Seoul 110-744, Korea, Republic of

Investigational Site Number 410002, Seoul 138-736, Korea, Republic of

Investigational Site Number 410003, Seoul 135-710, Korea, Republic of

Investigational Site Number 484001, Villahermosa 86100, Mexico

Investigational Site Number 504001, Casablanca 20000, Morocco

Investigational Site Number 504002, Rabat 10000, Morocco

Investigational Site Number 504003, Rabat, Morocco

Investigational Site Number 608002, Quezon City, Philippines

Investigational Site Number 764001, Bangkok 10330, Thailand

Investigational Site Number 764002, Chiang Mai 50200, Thailand

Investigational Site Number 788002, Sousse 4000, Tunisia

Investigational Site Number 788003, Tunis 1006, Tunisia

Investigational Site Number 792003, Abacioglu 34662, Turkey

Investigational Site Number 792001, Ankara 06100, Turkey

Investigational Site Number 792002, Istanbul 34303, Turkey

Additional Information

Starting date: November 2007
Last updated: July 2, 2015

Page last updated: August 20, 2015

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