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

Purpose

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.

Condition	Intervention	Phase
Nasopharyngeal Neoplasms Carcinoma	Drug: docetaxel (Taxotere®, XRP6976) Drug: cisplatin Drug: 5-fluorouracil (5-FU)	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Cisplatin Docetaxel

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Complete Response (CR) [ Time Frame: after the completion of the induction treatment (up to 9 weeks) ] [ Designated as safety issue: No ]
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. Complete response 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.

Secondary Outcome Measures:

Docetaxel Area Under the Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group [ Time Frame: Three plasma samples: one just before then 45mn and 5h after the end of cycle 1 infusion ] [ Designated as safety issue: No ]
AUC estimated by Bayesian method using concentration-time data for each patient and the previously defined adult population model as prior information (with validity of the estimation verified).
Overall Response (OR) [ Time Frame: after the completion of the consolidation treatment (up to 18 weeks) ] [ Designated as safety issue: No ]
OR classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or Unknown (UNK) on completion of both induction and radiation treatment and assessed according to the Modified RECIST from the NCI.
Overall Survival (OS) [ Time Frame: 3 years after the end of the consolidation treatment period (up to 40 months from randomization) ] [ Designated as safety issue: No ]
Time from randomization to death from any cause.

Enrollment:	75
Study Start Date:	November 2007
Study Completion Date:	January 2012
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Docetaxel/Cisplatin/5-FU (TCF) Docetaxel 75 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 Day 1 to 4 every 3 weeks as an induction therapy	Drug: docetaxel (Taxotere®, XRP6976) Pharmaceutical form:solution for infusion Route of administration:intravenous Other Name: Taxotere® Drug: cisplatin Pharmaceutical form:solution for infusion Route of administration:intravenous Drug: 5-fluorouracil (5-FU) Pharmaceutical form:solution for infusion Route of administration:intravenous Other Name: 5-FU
Active Comparator: Cisplatin/5-FU (CF) 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	Drug: cisplatin Pharmaceutical form:solution for infusion Route of administration:intravenous Drug: 5-fluorouracil (5-FU) Pharmaceutical form:solution for infusion Route of administration:intravenous Other Name: 5-FU

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 patients: Radiation Therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m2 every 21 days.

Eligibility

Ages Eligible for Study:	1 Month to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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, patients must be ≥1 year to ≤21 years of age at the time of diagnosis

Exclusion Criteria:

Patients 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 patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565448

Show 26 Study Locations

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00565448 History of Changes
Other Study ID Numbers:	EFC10339
Study First Received:	November 29, 2007
Results First Received:	March 5, 2010
Last Updated:	June 21, 2012
Health Authority:	United States: Food and Drug Administration Hong Kong: Ethics Committee India: Ministry of Health Turkey: Ministry of Health

Keywords provided by Sanofi:

Nasopharyngeal carcinoma

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
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 22, 2013