Eligibility Criteria

Patients will be considered eligible for enrolment into this trial if they fulfil all of the inclusion criteria and none of the exclusion criteria, as defined below:

Patient inclusion criteria

  1. Females aged ≥ 18 years with previous histologically proven diagnosis of :

    Epithelial ovarian carcinoma
    Fallopian tube carcinoma
    Primary serous peritoneal carcinoma

    Requiring treatment with further platinum-based chemotherapy ≥ 6 months after their last cycle of first-line chemotherapy and 6 weeks after maintenance that is not chemotherapy based.
  2. Signed informed consent and ability to comply with the protocol
  3. Ability to commence treatment within approximately 2 weeks of randomisationc
  4. CT or MRI proven relapsed disease (measurable or non-measureable)d
  5. ECOG performance status 0-1e
  6. Life expectancy more than 12 weeks
  7. If there is a past history of a solid tumour (other than ovarian cancer), this must have been treated curatively more than five years ago with no evidence of recurrence, with the exception of patients who have synchronous endometrial cancer (Stage I G1,G2) with their ovarian cancer
  8. If prior anthracycline or chest radiotherapy, Left Ventricular Ejection Fraction (LVEF) > institutional lower limit of normal
  9. Adequate bone marrow function:

    Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/l
    Platelets (Plt) ≥ 100 x 109/l
    Haemoglobin (Hb) ≥ 9g/dl (can be post transfusion)
  10. Adequate liver function (within 14 days before randomisation):

    Serum bilirubin (BR) ≤ 1.5 x ULN
    Serum transaminases ≤ 2.5 x ULNf
  11. Adequate renal function:

    Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance >50 ml/min
    Urine dipstick for proteinuria <2+. If urine dipstick is ≥ 2+ on two occasions more than one week apart then a 24 hour urine must demonstrate
    ≤ 1 g of protein in 24 hours or protein/creatinine ratio < 1.5.

Patient 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 approximately 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 (NYHAg) ≥ 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
  15. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory in the case of suspected brain metastases. Spinal MRI is mandatory in the case of suspected spinal cord compression. Patients with unstable, untreated brain or meningeal metastases are not eligible
  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 (for more details see section 6.3 in the proocol)

c - See trial assessments schedule for more details - table 2 in the protocol
d - The initial baseline scan should be done within 4 weeks prior to randomisation. However, a six week window would be considered after discussion with the CI
e - See Appendix 1 in the protocolf If the abnormal liver function tests are clearly attributable to liver metastases then serum transaminases (ALT and/or AST) values < 5x ULN are permitted
g - See Appendix 2 in the protocol


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