| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Locally recurrent or metastatic squamous call carcinoma of the head and neck |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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 |
|
| E.2.2 | Secondary objectives of the trial |
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.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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) .
|
|
| E.5 End points |
| E.5.1 | 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 each evaluation, five lesions will be selected for measurement at baseline.
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| 3 years after the last patient recruited in to the study has completed chemptherapy or death of the last patient, which ever is the sooner. Patients in the trial population have an expected survival of 6-9 months. This will allow the trial to complete and allow data review if there are any unexpected long term survivors following the treatment. Overall survival is a secondary outcome measure of the protocol so the majority of patients remain on follow up until death. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | |
| E.8.9.1 | In the Member State concerned days | |
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