An RCT of Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer

Exclusion Criteria

• •1. Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum
• •2. Poorly controlled hypertension (persistently elevated \> 150/100mmHg, either systolic or diastolic or both, despite anti-hypertensive medication)
• •3. History of inflammatory bowel disease (Crohn's disease or Ulcerative Colitis)
• •4. Malignancies other than ovarian cancer within 5 years prior to randomisation, except for synchronous endometrial cancer (Stage I G1,G2) with ovarian cancer,adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer. Patients who have a past history of a solid tumour, treated curatively, more than five years prior to randomisation, with no evidence of recurrence, are still eligible to enter ICON6.
• •5. Previous radiotherapy within 21 days prior to anticipated start of treatment
• •6. Treatment with any other investigational agent within 6 weeks prior to entering this trial. Patients are still eligible for entry into ICON6 if they have received previous treatment for ovarian cancer with either bevacizumab, erlotinib, or a Cox-2 inhibitor as long as more than 6 weeks have elapsed since the last treatment.
• •7. Arterial thrombotic event (including transient ischaemic attack \[TIA\], cerebrovascular accident \[CVA) and peripheral arterial embolus) within the previous 12 months.
• •8. GI impairment that could affect ability to take, or adsorption of, oral medicines including sub acute or complete bowel obstruction
• •9. Known hypersensitivity to cediranib or other VEGF inhibitors
• •10. Major surgery within 2 weeks before anticipated start of treatment
• •11. Significant haemorrhage of \> 30ml in a single episode within 3 months or any haemoptysis
• •12. Evidence of severe or uncontrolled cardiac disease
• •* Myocardial infarct \[MI\] or unstable angina within 12 months
• •* New York Health Association (NYHA) ≥ grade 2 congestive heart failure (CHF)
• •* Cardiac ventricular arrhythmias requiring medication.
• •* History of 2nd or 3rd degree atrioventricular conduction defects.
• •13. Prolonged QTc (corrected) interval of \> 470msec on ECG, or a family history of long QT syndrome.
• •14. Persisting ≥ Grade 2 CTC toxicity (except alopecia and neuropathy) from previous anti-cancer treatment. If peripheral sensory or motor neuropathy ≥ grade 2 then paclitaxel can be omitted from the chemotherapy at the discretion of the treating physician
• •16. Inability to attend or comply with treatment or follow-up scheduling
• •17. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
• •18. Fertile women of childbearing potential not willing to use adequate contraception for the duration of trial treatment and at least 6 months after.
• •19. Any other severe uncontrolled medical condition or disease
• •20. Concomitant use of potent inhibitors of CYP3A4 and 2C8 which cannot be stopped without a 2 week washout period before starting Trial Drug.