Expired Study
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Bridgewater, New Jersey 08807


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

EFC10339


NCT ID:

NCT00565448


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

1 Month


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sanofi-Aventis


Oversight Authority:

  • United States: Food and Drug Administration
  • Hong Kong: Ethics Committee
  • India: Ministry of Health
  • Turkey: Ministry of Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Sciences & Operations
Study Director
Sanofi-Aventis

Study Dates

Start Date:November 2007
Completion Date:January 2012
Completion Type:Actual
Primary Completion Date:March 2009
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 27, 2012
First Received Date:November 29, 2007
First Results Date:March 5, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall Survival (OS)
Time Frame:3 years after the end of the consolidation treatment period (up to 40 months from randomization)
Safety Issues:False
Description:Time from randomization to death from any cause.
Outcome Type:Secondary Outcome
Measure:Overall Response (OR)
Time Frame:after the completion of the consolidation treatment (up to 18 weeks)
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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).
Outcome Type:Primary Outcome
Measure:Complete Response (CR)
Time Frame:after the completion of the induction treatment (up to 9 weeks)
Safety Issues:False
Description: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 rad

Study Interventions

Intervention Type:Drug
Name:docetaxel (Taxotere®, XRP6976)
Description:Pharmaceutical form:solution for infusion Route of administration:intravenous
Arm Name:Docetaxel/Cisplatin/5-FU (TCF)
Other Name:Taxotere®
Intervention Type:Drug
Name:cisplatin
Description:Pharmaceutical form:solution for infusion Route of administration:intravenous
Arm Name:Docetaxel/Cisplatin/5-FU (TCF)
Intervention Type:Drug
Name:5-fluorouracil (5-FU)
Description:Pharmaceutical form:solution for infusion Route of administration:intravenous
Arm Name:Docetaxel/Cisplatin/5-FU (TCF)
Other Name:5-FU

Study Arms

Study Arm Type:Active Comparator
Arm Name:Cisplatin/5-FU (CF)
Description: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
Study Arm Type:Experimental
Arm Name:Docetaxel/Cisplatin/5-FU (TCF)
Description: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

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sanofi-Aventis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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