locally advanced resectable larynx and hypopharynx squamous cell carcinoma MedDRA version: 8.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck
Conditions
Interventions
Product Name: lapatinib
Product Code: GW572016
Pharmaceutical Form: Tablet
INN or Proposed INN: Lapatinib
Current Sponsor code: GW 572016
Other descriptive name: Lapatinib ditosylate
Concentration uni
Sponsors
European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically proven newly diagnosed laryngeal and hypopharyngeal cancer. ? Patients with T3 or T4 larynx or T2, T3 T4 hypopharynx ? Nodal status must be N0, N1, N2a, N2b, N2c and N3 ? Patients must consent to access of their biological material for EGFR status and must consent to PET ? Patient must have tumors amenable to surgery ? Absence of distant metastasis ? No prior treatment for head and neck cancer ? Age above 18 ? WHO PS 0-2 ? Normal hematological functions: neutrophils superior or equal to 1.5 x109 cells/l, platelets superior or equal to 100 x109 cells/l. ? Normal liver functions: bilirubin 180mm Hg or diastolic greater than 100mm Hg) ? Drugs and several HERBAL CONSTITUENTS (e.g. bergamottin and glabridin), which are inducers or inhibitors of CYP3A4 must not be taken within 10 days prior to initiation of treatment and are prohibited while the patient is being treated with lapatinib (a detailed list is provided in chapter 5) ? All patients (male and female) must use effective contraception methods according to CPMP/ICH/286/95 if of reproductive potential (e.g. implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner). Contraception methods should be used from 2 weeks before the start of treatment and until 4 weeks after the end of treatment. - Females must not be pregnant (negative serum pregnancy test at entry) or lactating Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint will be to determine the maximal tolerated dose (MTD), dose limiting toxicities (DLTs), and recommended dose of lapatinib. DLTs will be documented during first and second cycles of neoadjuvant chemotherapy to allow dose escalation but determination of recommended dose will be documented with both DLT rules and based on 80% dose intensity (rule of 80% dose intensity will be applied during the whole treatment duration from the start of neoadjuvant chemotherapy to the end of concomitant chemoradiation).;Main Objective: The primary objective is to determine the maximal tolerated dose, and recommended dose for phase II of lapatinib when concomitantly administered with neoadjuvant chemotherapy with TPF ( Taxotere, Cisplatin, 5-FU) followed by chemoradiation with carboplatin.;Secondary Objective: | — |
Countries
Belgium
Outcome results
None listed