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

Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565448
• Other study ID #: EFC10339
• Secondary ID: 2007-001211-33
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2007
• Last updated: July 2, 2015
• Start date: November 2007
• Est. completion date: January 2012

Study information

• Verified date: July 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationHong Kong: Ethics CommitteeIndia: Ministry of HealthTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2012
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 21 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• docetaxel
Pharmaceutical form:solution for infusion Route of administration:intravenous
• cisplatin
Pharmaceutical form:solution for infusion Route of administration:intravenous
• 5-fluorouracil
Pharmaceutical form:solution for infusion Route of administration:intravenous

Locations

Country	Name	City	State
Algeria	Investigational Site Number 012001	Alger
Brazil	Investigational Site Number 076002	Rio De Janeiro
Brazil	Investigational Site Number 076001	Sao Paulo
China	Investigational Site Number 156005	Fuzhou
France	Investigational Site Number 250001	Villejuif Cedex
India	Investigational Site Number 356003	Ahmedabad
India	Investigational Site Number 356004	Kolkata
India	Investigational Site Number 356002	Thiruvananthapuram
India	Investigational Site Number 356001	Vellore
Indonesia	Investigational Site Number 360001	Jakarta
Italy	Investigational Site Number 380001	Milano
Korea, Republic of	Investigational Site Number 410001	Seoul
Korea, Republic of	Investigational Site Number 410002	Seoul
Korea, Republic of	Investigational Site Number 410003	Seoul
Mexico	Investigational Site Number 484001	Villahermosa
Morocco	Investigational Site Number 504001	Casablanca
Morocco	Investigational Site Number 504002	Rabat
Morocco	Investigational Site Number 504003	Rabat
Philippines	Investigational Site Number 608002	Quezon City
Thailand	Investigational Site Number 764001	Bangkok
Thailand	Investigational Site Number 764002	Chiang Mai
Tunisia	Investigational Site Number 788002	Sousse
Tunisia	Investigational Site Number 788003	Tunis
Turkey	Investigational Site Number 792003	Abacioglu
Turkey	Investigational Site Number 792001	Ankara
Turkey	Investigational Site Number 792002	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Algeria,  Brazil,  China,  France,  India,  Indonesia,  Italy,  Korea, Republic of,  Mexico,  Morocco,  Philippines,  Thailand,  Tunisia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complete Response (CR)	CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.	after the completion of the induction treatment (up to 9 weeks)	No
Secondary	Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group	AUC estimated by Bayesian method using concentration-time data for each participant and the previously defined adult population model as prior information (with validity of the estimation verified).	Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion	No
Secondary	Overall Response (OR)	OR is classified as CR, partial response (PR), stable disease (SD), progressive disease (PD) or Unknown on completion of both induction and radiation treatment and assessed according to the Modified RECIST from the NCI. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as =30% decrease in the sum of the longest diameters (LD) of TLs, taking as reference the disease measurement done at study entry. PD is defined as =20% increase in the sum of the LD of TLs, taking as a reference the smallest disease measurement recorded at study entry or the appearance of =1 new lesions or unequivocal progression of non-TLs. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.	after the completion of the consolidation treatment (up to 18 weeks)	No
Secondary	Overall Survival (OS) Rate	OS rate is the percentage of participants who survived 3 years after completion of consolidation treatment period. The Kaplan-Meier method was used to estimate OS rate.	3 years after the end of the consolidation treatment period (up to 40 months from randomization)	No