International Multicentre Study in Advanced Anal Cancer Comparing Cisplatin Plus 5 FU vs Carboplatin Plus Weekly Paclitaxel

Exclusion Criteria

• •1. Tumours of adenocarcinoma, melanoma, small cell and basal cell histology are excluded.
• •2. Previous chemotherapy, radiotherapy or other investigational drug for surgically unresectable locally recurrent or advanced squamous cell carcinoma of the anus
• •3. Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
• •4. Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
• •5. Surgery or palliative radiotherapy within 28 days of randomisation.
• •6. Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months). Any history of clinically significant cardiac failure.
• •7. History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.
• •8. Lack of physical integrity of the gastro-intestinal tract, malabsorption syndrome (naso-gastric or jejunostomy feeding tube is permitted).
• •9. Acute hepatitis C and/or chronic active hepatitis B infection.
• •10. Serious active infection requiring i.v. antibiotics at enrolment.
• •11. Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
• •12. Other clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this trial.
• •13. Known hypersensitivity to any of the study drugs or excipients.
• •14. Known peripheral neuropathy ≥ grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible).
• •15. Pre-existing hearing impairment.
• •16. Patients planning for a live vaccine.
• •17. Pregnant or lactating females.