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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

docetaxel

cisplatin

5-fluorouracil

About this trial

This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring Nasopharyngeal carcinoma

Eligibility Criteria

1 Month - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Docetaxel/Cisplatin/5-FU (TCF)

Cisplatin/5-FU (CF)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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.

Full Information

NCT ID

NCT00565448

First Posted

November 29, 2007

Last Updated

July 2, 2015

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00565448

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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 participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Neoplasms, Carcinoma

Keywords

Nasopharyngeal carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Docetaxel/Cisplatin/5-FU (TCF)

Arm Type

Experimental

Arm Description

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.

Arm Title

Cisplatin/5-FU (CF)

Arm Type

Active Comparator

Arm 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. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.

Intervention Type

Drug

Intervention Name(s)

docetaxel

Other Intervention Name(s)

Taxotere®, XRP6976

Intervention Description

Pharmaceutical form:solution for infusion Route of administration:intravenous

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

Pharmaceutical form:solution for infusion Route of administration:intravenous

Intervention Type

Drug

Intervention Name(s)

5-fluorouracil

Other Intervention Name(s)

5-FU

Intervention Description

Pharmaceutical form:solution for infusion Route of administration:intravenous

Primary Outcome Measure Information:

Title

Number of Participants With Complete Response (CR)

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 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.

Time Frame

after the completion of the induction treatment (up to 9 weeks)

Secondary Outcome Measure Information:

Title

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

Description

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).

Time Frame

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

Title

Overall Response (OR)

Description

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.

Time Frame

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

Title

Overall Survival (OS) Rate

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility 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, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 012001

City

Alger

ZIP/Postal Code

16005

Country

Algeria

Facility Name

Investigational Site Number 076002

City

Rio De Janeiro

ZIP/Postal Code

20230-130

Country

Brazil

Facility Name

Investigational Site Number 076001

City

Sao Paulo

ZIP/Postal Code

04023-062

Country

Brazil

Facility Name

Investigational Site Number 156005

City

Fuzhou

ZIP/Postal Code

350014

Country

China

Facility Name

Investigational Site Number 250001

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Investigational Site Number 356003

City

Ahmedabad

ZIP/Postal Code

380006

Country

India

Facility Name

Investigational Site Number 356004

City

Kolkata

ZIP/Postal Code

700054

Country

India

Facility Name

Investigational Site Number 356002

City

Thiruvananthapuram

ZIP/Postal Code

695011

Country

India

Facility Name

Investigational Site Number 356001

City

Vellore

ZIP/Postal Code

632004

Country

India

Facility Name

Investigational Site Number 360001

City

Jakarta

ZIP/Postal Code

10430

Country

Indonesia

Facility Name

Investigational Site Number 380001

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Investigational Site Number 410001

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Investigational Site Number 410003

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Investigational Site Number 410002

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Investigational Site Number 484001

City

Villahermosa

ZIP/Postal Code

86100

Country

Mexico

Facility Name

Investigational Site Number 504001

City

Casablanca

ZIP/Postal Code

20000

Country

Morocco

Facility Name

Investigational Site Number 504002

City

Rabat

ZIP/Postal Code

10000

Country

Morocco

Facility Name

Investigational Site Number 504003

City

Rabat

Country

Morocco

Facility Name

Investigational Site Number 608002

City

Quezon City

Country

Philippines

Facility Name

Investigational Site Number 764001

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Investigational Site Number 764002

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Investigational Site Number 788002

City

Sousse

ZIP/Postal Code

4000

Country

Tunisia

Facility Name

Investigational Site Number 788003

City

Tunis

ZIP/Postal Code

1006

Country

Tunisia

Facility Name

Investigational Site Number 792003

City

Abacioglu

ZIP/Postal Code

34662

Country

Turkey

Facility Name

Investigational Site Number 792001

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Investigational Site Number 792002

City

Istanbul

ZIP/Postal Code

34303

Country

Turkey

Nasopharyngeal Neoplasms, Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial