A Pilot Study of Taxotere (Docetaxel), Cisplatin and 5FU (TPF) in the Palliative Treatment of Squamous Cell Carcinoma of the Head and Neck - tinpat

Conditions: ocally recurrent or metastatic squamous call carcinoma of the head and neck

Registration Number: EUCTR2006-005816-29-GB

Lead Sponsor: Royal Wolverhampton Hospitals Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

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

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.Hb<10g/dl that cannot be corrected by blood transfusion.
2.Neutrophil count<1.5x 109/L
3.Platelets<100x109/L
4.Serum bilirubin >1.5xULN
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) .