Phase I/II Study of Induction Chemotherapy With Weekly RAD001, Carboplatin and Paclitaxel in Unresectable or Inoperable Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of everolimus when combined with carboplatin
and paclitaxel in chemonaïve patients with unresectable or inoperable locally advanced
head and neck squamous cell carcinoma. (Phase I)
- To determine the safety profile of weekly everolimus in combination with carboplatin
and paclitaxel in chemonaïve patients with unresectable or inoperable locally advanced
head and neck squamous cell carcinoma. (Phase I)
- To determine the anti-tumor activity of this regimen, in terms of objective response
rate of the combination, according to the RECIST criteria in these patients. (Phase II)
Secondary
- To identify molecular markers of resistance to this regimen in these patients.
- To assess objective response rate before and after completion of radiation therapy in
these patients. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of everolimus followed by a
phase II study.
- Phase I: Patients receive paclitaxel IV over 1 hour, carboplatin IV over 1 hour, and
escalating doses of oral everolimus on days 1, 8, and 15. Treatment repeats every 21
days for 3 courses in the absence of disease progression or unacceptable toxicity.
- Phase II: Patients receive paclitaxel and carboplatin as in phase I and oral everolimus
(at a dose determined in the phase I portion of the study) on days 1, 8, and 15.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity.
After the completion of combination therapy, patients may receive radiotherapy or surgery,
at the investigator's discretion.
Blood samples are collected for translational research and molecular markers analysis at
baseline and weeks 1, 4, and 9. Tissue samples are collected at baseline and periodically
during the study for biomarker and other laboratory analysis.
After completion of study treatment, patients are followed up at 14 days and periodically
thereafter.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
to determine the maximum tolerated dose (MTD) and recommended dose of weekly RAD001 in combination with carboplatin and paclitaxel (phase I)
weekly
Yes
Sandrine Faivre
Principal Investigator
Hopital Beaujon
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CDR0000698330
NCT01333085
October 2009
May 2013
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