Overview

Preoperative TPF Chemotherapy in a Population of Molecularly Selected Locally Advanced Resectable Oral Cavity Squamous Cell Cancer

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
Summary
This is a phase II study of preoperative chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in locally advanced resectable oral cavity squamous cell cancer. The aim is to improve the rate of pathological complete response to induction chemotherapy in a molecular enriched population, consisting of patients with tumour harbouring a functional p53 protein and/or showing low expression of beta-tubulin II.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Treatments:
Docetaxel
Fluorouracil
Criteria
Inclusion Criteria:

- Signed informed consent

- Males and females age > 18 years

- Histologically proved primary oral cavity squamous cell cancer (tumour extending to
oropharynx are accepted if oropharyngeal invasion is < 20% of the tumour size)

- Stage T2 (T2 stage is accepted if tumour size is 3 cm or larger).-T3, N1- N3 and T4a
any N

- WHO performance status < 1

- Availability of block of Formalin Fixed Paraffin Embedded (FFPE) biopsy of the tumour

- Radiological imaging of the tumour with MRI pre-therapy

- Effective contraception for both male and female subjects if risk of conception exists

Exclusion Criteria:

- Prior antitumour therapy for head & neck cancer (chemotherapy or biological therapy
and radiotherapy)

- Metastatic disease

- Medical condition that contraindicate administration of TPF scheme, in particular:

1. clinically significant cardiac disease including unstable angina, acute
myocardial infarction in the previous 2 years, congestive heart failure and
arrhythmia requiring therapy

2. chronic or current infectious disease that contraindicate administration of
chemotherapy causing neutropenia; known HIV, Hepatitis B or C positivity

3. uncontrolled renal, hepatic, neurological, cerebral, psychiatric, haematological,
gastrointestinal, pulmonary, vascular or endocrine diseases that could interfere
with antiblastic treatment

- Pre-existing peripheral neuropathy according to Common Toxicity Criteria (CTC) Adverse
Event grade > 1

- Pre-existing ototoxicity grade > 1

- Previous diagnosis of other cancer in the last 3 years (in situ cervical cancer or
completely excised basocellular/squamocellular skin cancer are always admitted )

- Previous other cancer in oral cavity to less than 2 cm from existing primary

- Breast feeding women or women with a positive pregnancy test at Visit 0 or 1

- Screening laboratory values:

- Neutrophils < 1.5 x 109/L

- Platelets < 100 x 109/L

- ALT or AST > 2.5 times upper limit of normal

- Calculated creatinine clearance < 60 mL/min

- Weight loss more than 20% in 3 months preceding the study

- Technical unresectability defined as: T4b staging or N ulcerating the skin or
encasing internal carotid