Trial record 9 of 193 for:    nasopharyngeal cancer | "Nasopharyngeal Neoplasms"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00565448
First received: November 29, 2007
Last updated: June 21, 2012
Last verified: June 2012
  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:


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
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: 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:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014