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

NCT00565448 | Completed Phase 2 Results DMC

• 2 other identifiers: EFC103392007-001211-33
• Study Type: interventional
• Target: 75
• Locations: 13 countries
• Sites: 24

Brief 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.

Conditions

Nasopharyngeal Neoplasms; Carcinoma

Keywords

Nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

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

  Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion

• Overall Response (OR)

  after the completion of the consolidation treatment (up to 18 weeks)

• Overall Survival (OS) Rate

  3 years after the end of the consolidation treatment period (up to 40 months from randomization)

Study Arms (2)

Docetaxel/Cisplatin/5-FU (TCF)

EXPERIMENTAL

* Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks * Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks * 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.

Drug: docetaxel; Drug: cisplatin; Drug: 5-fluorouracil

Cisplatin/5-FU (CF)

ACTIVE COMPARATOR

* Cisplatin 80 mg/m² Day 1 over 6 hours every 3 weeks * 5-Fluorouracil 1000 mg/m²/day continuous infusion Day 1 to 4 every 3 weeks as an induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.

Drug: cisplatin; Drug: 5-fluorouracil

Interventions

docetaxel DRUG

Pharmaceutical form:solution for infusion Route of administration:intravenous

Also known as: Taxotere®, XRP6976

Docetaxel/Cisplatin/5-FU (TCF)

cisplatin DRUG

Pharmaceutical form:solution for infusion Route of administration:intravenous

Cisplatin/5-FU (CF); Docetaxel/Cisplatin/5-FU (TCF)

5-fluorouracil DRUG

Pharmaceutical form:solution for infusion Route of administration:intravenous

Also known as: 5-FU

Cisplatin/5-FU (CF); Docetaxel/Cisplatin/5-FU (TCF)

Eligibility Criteria

• Age: 1 Month - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (26)

Investigational Site Number 012001

Algiers, 16005, Algeria

Location

Investigational Site Number 076002

Rio de Janeiro, 20230-130, Brazil

Location

Investigational Site Number 076001

São Paulo, 04023-062, Brazil

Location

Investigational Site Number 156005

Fuzhou, 350014, China

Location

Investigational Site Number 250001

Villejuif, 94805, France

Location

Investigational Site Number 356003

Ahmedabad, 380006, India

Location

Investigational Site Number 356004

Kolkata, 700054, India

Location

Investigational Site Number 356002

Thiruvananthapuram, 695011, India

Location

Investigational Site Number 356001

Vellore, 632004, India

Location

Investigational Site Number 360001

Jakarta, 10430, Indonesia

Location

Investigational Site Number 380001

Milan, 20133, Italy

Location

Investigational Site Number 484001

Villahermosa, 86100, Mexico

Location

Investigational Site Number 504001

Casablanca, 20000, Morocco

Location

Investigational Site Number 504002

Rabat, 10000, Morocco

Location

Investigational Site Number 504003

Rabat, Morocco

Location

Investigational Site Number 608002

Quezon City, Philippines

Location

Investigational Site Number 410001

Seoul, 110-744, South Korea

Location

Investigational Site Number 410003

Seoul, 135-710, South Korea

Location

Investigational Site Number 410002

Seoul, 138-736, South Korea

Location

Investigational Site Number 764001

Bangkok, 10330, Thailand

Location

Investigational Site Number 764002

Chiang Mai, 50200, Thailand

Location

Investigational Site Number 788002

Sousse, 4000, Tunisia

Location

Investigational Site Number 788003

Tunis, 1006, Tunisia

Location

Investigational Site Number 792003

Abacıoğlu, 34662, Turkey (Türkiye)

Location

Investigational Site Number 792001

Ankara, 06100, Turkey (Türkiye)

Location

Investigational Site Number 792002

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma

Interventions

Docetaxel; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Trial Transparency Team
• Organization: sanofi

Contact-us@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: January 1, 2012
• Last Updated: July 30, 2015
• Results First Posted: March 25, 2010

Record last verified: 2015-07

Locations

TU (3); ID (1); CN (1); MO (3); BR (2); PH (1); IT (1); FR (1); ME (1); KR (3); TH (2); IN (4); AL (1)