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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Carcinoma; Nasopharyngeal Neoplasms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00565448

2007-001211-33 (EudraCT Number)

EFC10339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 1 month to 21 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Docetaxel/Cisplatin/5-FU (TCF)

Experimental group

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.

Treatment:

Drug: 5-fluorouracil

Drug: docetaxel

Drug: cisplatin

Cisplatin/5-FU (CF)

Active Comparator group

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.

Treatment:

Drug: 5-fluorouracil

Drug: cisplatin