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Ovarian CancerPhase 3ICON6NCT00532194

An RCT of Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer

A Phase 3 study testing cediranib in people with Ovarian Cancer, run by Medical Research Council at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
cediranib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
486 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2007to Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • If prior anthracycline or chest radiotherapy, Left Ventricular Ejection Fraction (LVEF) > institutional lower limit of normal.
  • 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)
  • Adequate liver function (within 14 days before randomisation)
  • Serum bilirubin (BR) ≤ 1.5 x ULN
  • Serum transaminases ≤ 2.5 x ULN
  • 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

Who cannot join

  • 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 ICON6.
  • 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.
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  • 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
  • Significant haemorrhage of > 30ml in a single episode within 3 months or any haemoptysis
  • 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.
  • Prolonged QTc (corrected) interval of > 470msec on ECG, or a family history of long QT syndrome.
  • 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
  • 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.
  • Inability to attend or comply with treatment or follow-up scheduling
  • 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
  • Fertile women of childbearing potential not willing to use adequate contraception for the duration of trial treatment and at least 6 months after.
  • Any other severe uncontrolled medical condition or disease
  • Concomitant use of potent inhibitors of CYP3A4 and 2C8 which cannot be stopped without a 2 week washout period before starting Trial Drug.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University College London

    London, Greater London, WC1E 6BT

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
cediranib
Keywords
ovarian cancer, fallopian tube cancer, primary serous peritoneal cancer, gynaecological carcinoma, randomised controlled trial, Cediranib, AZD2171, efficacy
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cediranibDrug

    Also called AZD2171, Recentin

    Once-daily oral tablet starting dose 20mg

Study groups in NCT00532194
Study groupRoleWhat they receive
A (reference)Placebo comparatorPatients in this arm will receive standard platinum based chemotherapy plus a daily oral placebo tablet for the duration of chemotherapy and then until protocol defined disease progression occurs.
B (concurrent cediranib)Active comparatorPatients 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.
Receives: Drug: cediranib
C (concurrent and maintenance cediranib)Active comparatorPatients in this arm will receive standard platinum based chemotherapy plus a daily oral cediranib tablet during chemotherapy until protocol defined disease progression occurs.
Receives: Drug: cediranib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: Apr 2013

Secondary outcomes (3)

  1. Overall survival

    Measured: Q2 2016

  2. Toxicity

    Measured: Q2 2015

  3. Quality of Life

    Measured: Q2 2015

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionApr 2013
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00532194
Sponsor's protocol ID
2007-001346-41
Other IDs
ISRCTN68510403, 2007-001346-41
Acronym
ICON6
Status last verified
Sep 2015
First submitted
19 Sep 2007
Last updated
23 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Raja FA, Griffin CL, Qian W, Hirte H, Parmar MK, Swart AM, Ledermann JA. Initial toxicity assessment of ICON6: a randomised trial of cediranib plus chemotherapy in platinum-sensitive relapsed ovarian cancer. Br J Cancer. 2011 Sep 27;105(7):884-9. doi: 10.1038/bjc.2011.334. Epub 2011 Aug 30.

    PubMed 21878941

  • Ledermann J, Perren T, Raja F, Embleton A, Rustin GJS, Jayson G, Kaye SB, Swart AM, Vaughan M, Hirte H. Randomised double-blind phase III trial of cediranib (AZD 2171) in relapsed platinum sensitive ovarian cancer: Results of the ICON6 trial. Eur J Cancer 2013;49(Suppl. 3):S5 (LBA10).

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

  • Ledermann JA, Embleton-Thirsk AC, Perren TJ, Jayson GC, Rustin GJS, Kaye SB, Hirte H, Oza A, Vaughan M, Friedlander M, Gonzalez-Martin A, Deane E, Popoola B, Farrelly L, Swart AM, Kaplan RS, Parmar MKB; ICON6 collaborators. Cediranib in addition to chemotherapy for women with relapsed platinum-sensitive ovarian cancer (ICON6): overall survival results of a phase III randomised trial. ESMO Open. 2021 Apr;6(2):100043. doi: 10.1016/j.esmoop.2020.100043. Epub 2021 Feb 18.

    PubMed 33610123

  • Ledermann JA, Embleton AC, Raja F, Perren TJ, Jayson GC, Rustin GJS, Kaye SB, Hirte H, Eisenhauer E, Vaughan M, Friedlander M, Gonzalez-Martin A, Stark D, Clark E, Farrelly L, Swart AM, Cook A, Kaplan RS, Parmar MKB; ICON6 collaborators. Cediranib in patients with relapsed platinum-sensitive ovarian cancer (ICON6): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Mar 12;387(10023):1066-1074. doi: 10.1016/S0140-6736(15)01167-8.

    PubMed 27025186

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cediranib in people with Ovarian Cancer, run by Medical Research Council at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Apr 2013). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00532194, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.

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