Locally recurrent or metastatic squamous call carcinoma of the head and neck
Conditions
Interventions
Trade Name: TAxotere
Pharmaceutical Form: Concentrate and solvent for solution for injection
Trade Name: Cisplatin
Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Royal Wolverhampton Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Aged over 18 and less than or equal to 70 at study entry b) Histologically proven squamous carcinoma the head and neck, excluding carcinoma of the nasopharynx . c) Patients must have disease that is considered unsuitable for radical treatment with either surgery or radiotherapy. Either or both forms of treatment may have been used previously in patients who have progressive disease but measurable disease recurrence must be present outside of a previously irradiated area if radiotherapy was completed within 6 months of randomisation. d) Patients must be considered fit for chemotherapy. e) ECOG performance status of 0,1 or 2 f) Able and willing to give written informed consent and to comply with the protocol for the duration of treatment and follow up. g) Expected survival greater than 3 months from entry into study h) Adequate renal function. a. Calculated Cockroft/Gault GFR ? 60ml/min or b. EDTA GFR ? 50ml/min i) Measurable Disease. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Women who are lactating or pregnant. b) Patients who have received previous chemotherapy for recurrent malignant disease or any cytotoxic chemotherapy within 6 months prior to study entry. c) Patients who have received radiotherapy within 6 weeks or if they have ongoing acute radiotherapy toxicity. d) A history of nervous or psychiatric disorder that would preclude informed consent or compliance with oral drug intake or treatment e) A history of previous malignancy within the previous 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of cervix. f) Patients with the following laboratory values 1. Hb1.5xULN 5. ALT and/or AST>2.5xULN 6. Alkaline phosphatase>2.5xULN g) Patients with uncontrolled infection. h) Patients with a history of severe hypersensitivity reactions to Taxotere ( Docetaxel) .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the response rate ( CR plus PR ) and tolerability of Taxotere (Docetaxel) 75mg/m2 over 1 hr i.v. Day 1 plus Cisplatin i.v.75mg/m2 Day 1 over 2hrs plus 5FU 750 mg/m2 i.v. over 24hrs Day 1-4 (TPF) for the palliative treatment of squamous cell carcinoma of the head and neck. This is a phase 2 study of results are favourable we will progress to a phase 3 randomised study against the current gold standard of cisplatin and 5FU;Secondary Objective: To assess the effect of TPF therapy on Quality of Life in this population To assess the toxicity profile in this population. To assess time to progression and survival status. ;Primary end point(s): All patients who have at least two courses of TPF will be considered evaluable for efficacy analyses. The primary outcome measure of the study is percentage response rate (CR and PR). Tumours will be measured by the investigator in the most appropriate manner at baseline and at the end of course three and following cycle 6 . Reassessment of the tumour size will be performed using the same method used to establish baseline tumour measurements. Following completion of chemotherapy tumour measurements should be assessed clinically at each follow up visit. Radiological assessment should be performed as clinically indicated. Lesions will be measured in millimetres. A maximum of 5 target lesions per organ or a maximum of 10 lesions in total may be identified. The sum of the longest diameter of all target lesions for all target lesions will be calculated at baseline and will be the reference when determining response. An estimate of overall objective and subjective response will be made and recorded each visit. Measurable disease requires lesions with clearly defined margins and is defined a minimum of one lesion where the longest diameter is = 20mm on conventional CT or = 10mm on spiral CT or MRI. or direct clinical measurement = 10mm If an organ has too many measurable lesions to measure at ea | — |
Countries
United Kingdom
Outcome results
None listed