ISRCTN ISRCTN63407050
DOI https://doi.org/10.1186/ISRCTN63407050
EudraCT/CTIS number 2013-000293-29
Secondary identifying numbers ICR-CTSU/2012/10038
Submission date
03/04/2013
Registration date
24/05/2013
Last edited
09/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-abiraterone-for-women-with-ovarian-primary-peritoneal-or-fallopian-tube-cancer-coral

Contact information

Dr Susana Banerjee
Scientific

The Royal Marsden NHS Foundation Trust
Gynaecology Unit
Downs Road
Sutton
London
SM2 5PT
United Kingdom

Email coral-icrctsu@icr.ac.uk

Study information

Study designProspective open-label non-randomised two-stage phase II clinical trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Please use the contact information provided to request a Patient Information Sheet.
Scientific titleA phase II study of abiraterone in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer
Study acronymCORAL
Study objectivesThe study hypothesis is that abiraterone will show clinical activity in patients with epithelial ovarian cancer (EOC).

We also aim to identify biomarkers of abiraterone sensitivity in EOC and evaluate the molecular impact of abiraterone.
Ethics approval(s)NRES Committee London – Westminster, 22/10/2013, REC ref: 13/LO/1599
Health condition(s) or problem(s) studiedPatients with epithelial ovarian cancer (including fallopian tube and primary peritoneal) that has relapsed within 12 months of last treatment.
InterventionEvaluating the efficacy of abiraterone in patients with ovarian, including fallopian tube and primary peritoneal, cancer.
Oral abiraterone 1000mg (4x250mg) plus 5mg prednisone/prednisolone once a day
Patients will continue on trial treatment until disease progression. We anticipate the study running for around 3 years, from first patient recruited to last patient last data capture

Details of co-sponsor:
Royal Marsden NHS Foundation Trust
R&D Office
Royal Marsden Hospital
Downs Road
Sutton
United Kingdom
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Abiraterone
Primary outcome measureThe primary objective of this study is to determine whether abiraterone has clinical activity (objective response rate assessed by imaging and/or CA125 tumour marker changes in the blood) in patients with epithelial ovarian cancer.
Secondary outcome measures1. The proportion of patients with objective response according to RECIST
2. The proportion of patients with objective response according to GCIG (CA125)
3. Clinical benefit rate according to RECIST/GCIG criteria at 12 weeks
4. Progression Free Survival (PFS)
5. 6-month PFS
6. Time to Progression (TTP)
7. Overall survival (OS)
8. Toxicity according to CTCAE version 4.0
We will also explore the molecular impact of abiraterone and attempt to identify biomarkers of abiraterone sensitivity in epithelial ovarian cancer.
Overall study start date15/07/2013
Completion date14/07/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants47
Total final enrolment42
Key inclusion criteria1. Histologically or cytologically confirmed epithelial ovarian, fallopian tube (FT) or primary peritoneal (PP) cancer and have progressed (radiological or CA125 criteria) within 12 months of last systemic anti-cancer therapy
2. Life expectancy of at least 12 weeks
3. Post-menopausal defined as:
3.1. Aged ≥ 18 years having had bilateral salpingo-oophorectomy (BSO)
3.2. Aged ≥ 45 years with intact uterus and amenorrhoeic for at least 12 months
3.3. FSH >40 U/L in patients who have had a hysterectomy and ovaries are intact (i.e. not had bilateral oophorectomy)
Documented evidence is required for patients who have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy
4. ECOG performance status of 0-2
5. No prior hormone therapy (e.g. tamoxifen, aromatase inhibitor, progestogens, anti-androgens)
6. At least one line of prior platinum-based chemotherapy
7. Measurable or evaluable disease (if not measurable by RECIST v1.1 criteria, patients must be evaluable by GCIG CA125 criteria). See Appendix 2
8. Archival primary tumour tissue (FFPE or 8-10 unstained slides) must be available. Otherwise, a biopsy must be carried out to obtain sufficient tissue for histological assessment
9. No evidence of pre-existing uncontrolled hypertension as documented by two baseline blood pressure readings taken at least an hour apart. The baseline systolic blood pressure readings must be <160 and the baseline diastolic blood pressure readings must be <95 mmHg. Patients whose hypertension is controlled by antihypertensive therapies are eligible
10. Haematological and biochemical indices within acceptable specifed ranges
11. Aged 18 years or over
12. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
Key exclusion criteria1. Tumours of mucinous, clear cell, malignant mixed mesodermal (MMMT) or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours)
2. Radiotherapy (except for palliative reasons) or chemotherapy within the preceding three weeks (four weeks for investigational agent or within five half-lives of the investigational agent, whichever is longer)
3. Persistent grade 2 or greater toxicities from any cause except for alopecia or grade 2 peripheral neuropathy
4. Known leptomeningeal involvement or brain metastases
5. Clinical and/or biochemical evidence of hyperaldosteronism or hypopituitarism
6. Unresolved bowel obstruction
7. Major surgery within four weeks prior to entry to the study or minor surgery within two weeks of entry into the study and from which the patient has not yet recovered
8. Treatment with warfarin. Patients on warfarin for DVT/PE can be converted to LMWH at least one week prior to commencement of trial treatment
9. At high medical risk, as deemed by the Principal Investigator, because of non-malignant systemic disease including active uncontrolled infection
10. Known to be serologically positive for hepatitis B and/or hepatitis C
11. Active or uncontrolled autoimmune disease that may require corticosteroid therapy
12. History of clinically significant heart disease, e.g. myocardial infarction or arterial thrombotic event within six months, severe or unstable angina, or New York Heart Association Class III or IV heart disease
13. Systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg documented on at least two different occasions
[Note: Hypertension controlled by antihypertensive therapy is permitted].
14. Any other active malignancy requiring treatment/or whose prognosis will prevent readout from trial endpoints
15. Patients for whom treatment with prednisone or prednisolone is contraindicated
16. Patients participating in or planning to participate in another interventional clinical trial. Participation in an observational trial is acceptable
17. Any other condition which, in the Investigator’s opinion, would not make the patient a good candidate for the clinical trial
Date of first enrolment15/07/2013
Date of final enrolment31/12/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Royal Marsden NHS Foundation Trust
London
SM2 5PT
United Kingdom

Sponsor information

The Institute of Cancer Research (UK)
Research organisation

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website http://www.icr.ac.uk/
ROR logo "ROR" https://ror.org/043jzw605

Funders

Funder type

Industry

Study drug and funding provided by Janssen-Cilag

No information available

CORAL has received endorsement from Cancer Research UK (CRUK) (ref: A16037)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results results presented at the European Society of Medical Oncology (ESMO) conference 01/10/2016 26/10/2020 No No
Results article 29/12/2020 16/04/2021 Yes No
Plain English results 09/08/2022 No Yes
HRA research summary 28/06/2023 No No

Editorial Notes

09/08/2022: A link to plain English results summary on CRUK was added.
16/04/2021: Publication reference added.
26/10/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.