A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (With Platinum-based Chemotherapy) and Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer
Overview
- Phase
- Phase 3
- Intervention
- cediranib
- Conditions
- Ovarian Cancer
- Sponsor
- Medical Research Council
- Enrollment
- 486
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of cediranib in combination with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or epithelial cancer, after first line platinum based treatment.
Detailed Description
ICON6 is a randomised three-arm, two stage, double-blind, placebo-controlled multicentre Gynaecologic Cancer InterGroup (GCIG) phase III trial. All patients will receive 6 cycles of platinum-based chemotherapy. Trial drug will be administered for up to 18 months from randomisation or until progression, whichever is sooner. Patients who have not progressed at 18 months from randomisation can continue Trial Drug until progression, if in the opinion of the clinician and the patient there is continuing clinical benefit. Patients in Arm A (the reference arm) will receive a platinum-based chemotherapy regimen plus a daily oral placebo tablet for the duration of the chemotherapy and up to 18 months from randomisation or until progression. Patients in Arm B (concurrent cediranib arm) will also receive a platinum-based chemotherapy regimen plus daily oral cediranib during chemotherapy only, and then an oral daily placebo tablet up to 18 months from randomisation or until progression. Patients in Arm C (concurrent and maintenance cediranib arm) will also receive a platinum-based chemotherapy regimen plus oral cediranib daily during chemotherapy and then continued up to 18 months from randomisation or until progression.
Investigators
Andrew Embleton
ICON6 Statistician
Medical Research Council
Eligibility Criteria
Inclusion Criteria
- •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.
- •Signed informed consent and ability to comply with the protocol
- •Ability to commence treatment within approximately 2 weeks of randomisation
- •CT or MRI proven relapsed disease (measurable or non-measurable)
- •ECOG performance status 0-1
- •Life expectancy more than 12 weeks
- •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
Exclusion Criteria
- •Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum
- •Poorly controlled hypertension (persistently elevated \> 150/100mmHg, either systolic or diastolic or both, despite anti-hypertensive medication)
- •History of inflammatory bowel disease (Crohn's disease or Ulcerative Colitis)
- •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 ICON
- •Previous radiotherapy within 21 days prior to anticipated start of treatment
- •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.
- •Arterial thrombotic event (including transient ischaemic attack \[TIA\], cerebrovascular accident \[CVA) and peripheral arterial embolus) within the previous 12 months.
- •GI impairment that could affect ability to take, or adsorption of, oral medicines including sub acute or complete bowel obstruction
- •Known hypersensitivity to cediranib or other VEGF inhibitors
- •Major surgery within 2 weeks before anticipated start of treatment
Arms & Interventions
B (concurrent cediranib)
Patients in this arm will receive standard platinum based chemotherapy plus a daily oral cediranib tablet during chemotherapy only and then an oral daily placebo tablet until protocol defined disease progression occurs.
Intervention: cediranib
C (concurrent and maintenance cediranib)
Patients in this arm will receive standard platinum based chemotherapy plus a daily oral cediranib tablet during chemotherapy until protocol defined disease progression occurs.
Intervention: cediranib
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: Apr 2013
Secondary Outcomes
- Toxicity(Q2 2015)
- Quality of Life(Q2 2015)
- Overall survival(Q2 2016)