Clinical trial NCT00532194 (phase 3, status: unknown status)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cediranib
SMILES: COC1=CC2=C(C=C1OCCCN1CCCC1)N=CN=C2OC1=C(F)C2=C(NC(C)=C2)C=C1
Eligibility criteria:

        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 randomisation

          4. CT or MRI proven relapsed disease (measurable or non-measurable)

          5. ECOG performance status 0-1

          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 ULN

         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 <=1g of protein in
                  24 hours or protein/creatinine ratio <1.5

        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

         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.