Phase 2
N=75
Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
Nasopharyngeal Neoplasms · Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00565448 ↗Enrolled (actual)
75
Serious AEs
41.3%
Results posted
Mar 2010
Primary outcome: Primary: Number of Participants With Complete Response (CR) — 1; 0 participants — p=1.0000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- docetaxel (Drug); cisplatin (Drug); 5-fluorouracil (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Response (CR) |
1; 0 | 1.0000 |
| SECONDARY Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group |
3.43 | — |
| SECONDARY Overall Response (OR) |
1; 1; 43; 20; 2; 1 | — |
| SECONDARY Overall Survival (OS) Rate |
85.7; 78.0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00565448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.