A trial looking at cediranib for ovarian cancer that has come back (ICON6)
- Conditions
- Relapsed platinum-sensitive ovarian cancerCancerMalignant neoplasm of ovary
- Registration Number
- ISRCTN68510403
- Lead Sponsor
- Medical Research Council (UK)
- Brief Summary
2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21878941 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27025186 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28339098 quality of life results 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31347385/ results (added 02/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33610123/ (added 01/11/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 470
1. Females aged 18 years or older with previous histologically proven diagnosis of:
1.1. Epithelial ovarian carcinoma
1.2. Fallopian tube carcinoma
1.3. Primary serous peritoneal carcinoma
Relapsing more than 6 months after completion of first-line platinum-based chemotherapy
2. Signed informed consent and ability to comply with the protocol
3. Ability to commence treatment within 2 weeks of randomisation
4. Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) proven relapsed disease, more than six months since completion of first-line platinum-based chemotherapy
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
6. Life expectancy more than 12 weeks
7. If there is a past history of a solid tumour, this must have been treated curatively more than five years ago with no evidence of recurrence
8. Adequate bone marrow function
8.1. Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 109/l
8.2. Platelets (Plt) greater than or equal to 100 x 109/l
8.3. Haemoglobin (Hb) greater than or equal to 9g/dl (can be post transfusion)
9. Adequate liver function (within 14 days before randomisation)
9.1. Serum bilirubin (BR) = 1.5 x Upper Limit of Normal (ULN)
9.2. Serum transaminases = 2.5 x ULN
10.Adequate renal function
10.1. Serum creatinine = 1.5 ULN
10.2. Urine dipstick for proteinuria less than 2+. If urine dipstick is greater than or equal to 2+ on two occasions more than one week apart then a 24 hour urine must demonstrate less than or equal to 1 g of protein in 24 hours
1. Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum
2. Poorly controlled hypertension (persistently elevated >150/100 mmHg 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 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 randomisation
6. Treatment with any other investigational agent within 30 days 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 30 days 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. Gastrointestinal (GI) impairment that could affect ability to take, or adsorption of, oral medicines including sub acute or complete bowel obstruction
9. Known hypersensitivity to AZD2171 or other Vascular Endothelial Growth Factor (VEGF) inhibitors
10. Major surgery within 2 weeks before entry into the trial
11. Significant haemorrhage of >30 ml in a single episode within 3 months or any haemoptysis
12. Evidence of severe or uncontrolled cardiac disease
12.1. Myocardial Infarct (MI) or unstable angina within 12 months
12.2. New York Health Association (NYHA) = grade 2 Congestive Heart Failure (CHF)
12.3. Cardiac ventricular arrhythmias requiring medication
12.4. History of 2nd or 3rd degree atrioventricular conduction defects
13. Prolonged QTc (corrected) interval of >470 msec on electrocardiogram (ECG), or a family history of long QT syndrome
14. Persisting = Grade 2 CTC (Common Toxicity Criteria) 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 duratio
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measures as of 13/03/2015:<br> Progression-free survival (PFS) in arms A vs C<br><br> Previous primary outcome measures:<br> Stage 1: Safety<br> Stage 2: Progression free survival<br> Stage 3: Overall survival<br><br> Data for the outcomes above will be collected approximately 3 weekly during chemotherapy, 6 weekly after chemotherapy up to 18 months, 3 monthly up to 3 years, 6 monthly during years 4 and 5, then annually until protocol defined disease progression or death.<br>
- Secondary Outcome Measures
Name Time Method