NCT00532194

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
486

participants targeted

Target at P50-P75 for phase_3 ovarian-cancer

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_3 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

5.8 years

First QC Date

September 19, 2007

Last Update Submit

September 21, 2015

Conditions

Ovarian Cancer

Keywords

ovarian cancerfallopian tube cancerprimary serous peritoneal cancergynaecological carcinomarandomised controlled trialCediranibAZD2171efficacy

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Apr 2013

Secondary Outcomes (3)

  • Overall survival

    Q2 2016

  • Toxicity

    Q2 2015

  • Quality of Life

    Q2 2015

Study Arms (3)

A (reference)

PLACEBO COMPARATOR

Patients 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 COMPARATOR

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.

Drug: cediranib

C (concurrent and maintenance cediranib)

ACTIVE COMPARATOR

Patients in this arm will receive standard platinum based chemotherapy plus a daily oral cediranib tablet during chemotherapy until protocol defined disease progression occurs.

Drug: cediranib

Interventions

cediranibDRUG

Once-daily oral tablet starting dose 20mg

Also known as: AZD2171, Recentin
B (concurrent cediranib)C (concurrent and maintenance cediranib)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)
  • +6 more criteria

You may not qualify if:

  • 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.
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, Greater London, WC1E 6BT, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 21878941BACKGROUND

  • 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).

    RESULT

  • 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.

    PMID: 37185961DERIVED

  • 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.

    PMID: 33610123DERIVED

  • 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.

    PMID: 27025186DERIVED

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

cediranib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Jonathan Ledermann, Prof.

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ICON6 Statistician

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 20, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2013

Study Completion

December 1, 2016

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

GB(1)