epitehlial ovarian carcinoma, fallopian tube carcinoma, primary serous peritoneal carcinoma relapsing more than 6 months after completion of first-line platinum based chemotherapy MedDRA version: 14.1 Level: LLT Classification code 10033131 Term: Ovarian carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10052171 Term: Peritoneal carcinoma System Organ Class: 10029104 - Neoplasms benig
Conditions
Interventions
Product Code: AZD2171
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: AZD2171
Pharmaceuti
Sponsors
Medical Research Council
Eligibility
Sex/Gender
All
Inclusion 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-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 and calculated creatinine clearance >50 ml/min • Urine dipstick for proteinuria 2+ on two occasions more than one week apart then a 24 hour urine must demonstrate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the safety and efficacy of AZD2171 in combination with platinum-based chemotherapy and as a single agent maintenance therapy, in women with ovarian cancer relapsing more than 6 months following completion of first line platinum based treatment. The main outcome measure is Progression Free Survival (PFS);Secondary Objective: to assess overall survival, toxicity and quality of life (QoL) being secondary outcome measures ;Primary end point(s): Stage 1: safety Stage 2: progression free survival;Timepoint(s) of evaluation of this end point: The second stage will be analysed when approximately 176 events have been observed in arms A and C | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival (OS) Toxicity Quality of Life (QoL) | — |
Countries
Australia, Canada, New Zealand, Spain, United Kingdom
Contacts
Public ContactICON6 Trial Manager
Medical Research Council
Outcome results
None listed