Evaluation of the Tolerance of Afatinib in Combination With Docetaxel and Cisplatin in LAHNSCC Induction Chemotherapy
Status:
Completed
Trial end date:
2015-09-15
Target enrollment:
Participant gender:
Summary
The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib
administrated in combination with docetaxel (Taxotere®) and cisplatin in induction
chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II,
allowing the comparison with standard induction chemotherapy TPF.
It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib (20,
30 and 40 Mg per day) will be studied in combination with the fixed standard doses of
docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of
afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment
each one (9 weeks on the whole). The next dose level will be studied only if the previous
dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st
cycle more first week of the 2nd cycle). Once the MTD is determined, four additional patients
will be treated with this dose. A maximum of 22 patients should be included in this study.
The total duration of the study is estimated at 18 months. In case of major safety problems,
the study may be stopped earlier. In short, the preclinical data, pharmacological and
clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and
that the association of afatinib with cisplatin and docetaxel could be effective in patients
with head and neck squamous cell carcinoma potentially resulting in an extension of time to
progression.