A Phase I Study Evaluating the Combination Afatinib With Docetaxel and Cisplatin (TPA) in Induction Chemotherapy in Locally Advanced Squamous Cell Carcinoma of the Upper Aerodigestive Tract (TAPIS)

NCT02216617 Phase 1 COMPLETED

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.

Details

Lead sponsor	Groupe Oncologie Radiotherapie Tete et Cou
Phase	Phase 1
Status	COMPLETED
Enrolment	8
Start date	2014-08-06
Completion	2015-09-15

Conditions

• HNSCC

Interventions

• Taxotere, Cisplatin, Afatinib

Primary outcomes

• Maximum Tolerated Dose (MTD) — During the first 4 weeks of treatment for each patient of the bearing.
  The main objective is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with docetaxel and cisplatin chemotherapy TPA induction in locally advanced head and neck carcinomas in order to move a phase II for comparison with induction chemotherapy "of reference "TPF (Taxotere, cisplatin and 5-fluorouracil).

Countries

France