Status:
COMPLETED
Evaluation of the Tolerance of Afatinib in Combination With Docetaxel and Cisplatin in LAHNSCC Induction Chemotherapy
Lead Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Conditions:
HNSCC
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 advance...
Detailed Description
Cancers of the upper aerodigestive tract correspond in the Western countries about 5% of cancers. They are treated by surgery, radiotherapy, and chemotherapy. Although progress in radio chemotherapy h...
Eligibility Criteria
Inclusion
- Age ≥18 years and ≤70 years
- Patient in first line treatment of Locally Advanced HNSCC, histologically proven non-metastatic
- At least one measurable lesion (RECIST)
- Eligible patient for standard induction chemotherapy in the opinion of the investigator; PS ECOG \< 2
- Adequacy functioning of organs, including:
- Left ventricular function with ejection fraction at rest \> 50% or as normal institutional values Haematological function
- Absolute neutrophil count (ANC) \>1,500/mm3 Special cases: ANC\> 1,000/mm3 in the opinion of the investigator and discussion with the sponsor; Platelets ≥ 75,000/mm3; Hemoglobin\> 10g/dl
- Liver function:
- •Total bilirubin ≤ 1.5 x ULN; patients with Gilbert's syndrome must have a total bilirubin \<4 x ULN; SGOT and SGPT ≤ 3 x ULN or SGOT and SGPT ≤ 5 x ULN in case liver abnormalities; Alkaline phosphatase \<2.5 x ULN
- Kidney function:
- •Serum creatinine \<110 umol/L or creatinine clearance \> 45 ml/min (Cockcroft method)
- General:
- Men and women of childbearing potential must agree to use a reliable contraception throughout treatment and at least 6 months after the end of treatment. Women in peri-menopause should be least 24 months of amenorrhea.
- Ability to take oral medication in the opinion of the investigator; Patient affiliated to a social security system; signed informed consent form.
Exclusion
- •Previous treatment with chemotherapy, radiation therapy or targeted therapy for head and neck cancer; uncontrolled Respiratory, cardiac, hepatic or renal diseases.
- Significant cardiovascular disease like:
- Cardiovascular Abnormalities considered clinically important as congestive heart failure NYHA stage ≥ III, unstable angina or myocardial infarction within the past 6 months, or arrhythmia low controlled, uncontrolled hypertension by treatment (systolic BP ≥ 160 mmHg and/or diastolic BP≥ 90 mmHg).
- Impairment of left ventricular function with an ejection fraction ≤ 50%; Stroke within 6 months prior to inclusion.
- Severe thromboembolic history within 6 months prior to inclusion.
- Lengthening of the corrected QT interval with QTc\> 480 msec according to the formula Bazet; Bradycardia; Electrolyte disturbances
- Respiratory disease of type:
- •interstitial lung disease; Pulmonary fibrosis
- Viral disease of type:
- •Active infection or hepatic B virus or hepatitis C known carrier of HIV.
- Recent digestive disorder with diarrhea such as:
- Any history or presence of gastrointestinal disorders with uncontrolled diarrhea as a major symptom that may affect the absorption of drug tested in the opinion of the investigator (eg disease Crohn's disease, diarrhea CTCAE grade ≥ 2)
- Any past or present condition that would compromise the patient's ability to comply with the study or which would interfere with the evaluation of the effectiveness and the safety of the study.
- Other severe disease or condition associated with non-oncological origin likely to be incompatible with the protocol in the judgment of the investigator.
- Patient already included in another clinical trial with an experimental molecule; Persons deprived of liberty or under guardianship or as backup justice.
- Patient requiring prohibited concomitant treatments with study.
- Any cons-indication to treatment with Taxotere or Afatinib or cisplatin.
- Known hypersensitivity to Afatinib or excipients the study drugs; Major surgery within 4 weeks before taking treatment; Use of products in a clinical study during the 4 weeks preceding inclusion.
- Radiation therapy within 4 weeks before inclusion.
- •Presence and / or history (in the past 3 years) cancer except Basal cell skin cancer, cervical carcinoma in situ and prostate cancer in situ; Pregnant or during breastfeeding.
Key Trial Info
Start Date :
August 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02216617
Start Date
August 6 2014
End Date
September 15 2015
Last Update
October 27 2017
Active Locations (1)
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1
ICM Val d'Aurelle, Montpellier
Montpellier, France, 34298