Evaluation of the Tolerance of Afatinib in Combination With Docetaxel and Cisplatin in LAHNSCC Induction Chemotherapy (TAPIS)
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|ClinicalTrials.gov Identifier: NCT02216617|
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : October 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|HNSCC||Drug: Taxotere, Cisplatin, Afatinib||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 6, 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||September 15, 2015|
Experimental: Induction chemotherapy TPA
3 Cycles of induction chemotherapy TPA : (Taxotere, Cisplatin, Afatinib)
1 cycle = 3 weeks, three cycles of treatment in total (or 9 weeks)
Docetaxel 75 mg / m2 at D1 Cisplatin 75 mg / m 2 at D1 Afatinib: x mg / day D2 to D21 by level: (Level 1: 20 mg / day; Level 2: 30 mg / day; Level 3: 40 mg / day)
|Drug: Taxotere, Cisplatin, Afatinib|
- Maximum Tolerated Dose (MTD) [ Time Frame: 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).
- Tolerance [ Time Frame: 12 weeks ]Tolerance: Toxicity will be evaluated by NCI CTCAE V4.03. scale
- Efficacy [ Time Frame: 12 weeks ]Efficacy: Objective tumor response will be evaluated through RECIST V1.1
- Correlation between nutritional status and toxicity [ Time Frame: 12 weeks ]Objective is to correlate the values of body fat / lean mass determined by CT-scan to the nutritional status of the patients and toxicities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216617
|ICM Val d'Aurelle, Montpellier|
|Montpellier, France, 34298|
|Study Chair:||Didier CUPISSOL, MD||GORTEC|