Condition category
Cancer
Date applied
15/07/2008
Date assigned
30/07/2008
Last edited
22/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Martin Gore

ORCID ID

Contact details

Department of Medicine
Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom
Martin.Gore@rmh.nhs.uk

Additional identifiers

EudraCT number

2008-000837-23

ClinicalTrials.gov number

NCT01081262

Protocol/serial number

UCL/07/095

Study information

Scientific title

Acronym

mEOC

Study hypothesis

Current hypothesis as of 08/03/2011:
This trial aims to determine whether a combination of oxaliplatin + capecitabine improves overall survival compared to conventional treatment with carboplatin + paclitaxel in patients with advanced mucinous carcinoma of the ovary, and to determine if the addition of bevacizumab improves the overall survival of patients.

The two chemotherapy regimens will also be compared in terms of:
1. Progression free survival
2. Response rate
3. Toxicity
4. Quality of life

Previous hypothesis:
This trial aims to determine whether a combination of oxaliplatin + capecitabine improves overall survival compared to conventional treatment with carboplatin + paclitaxel in patients with advanced mucinous carcinoma of the ovary.

As of 08/03/2011 changes have been made to the trial record.The updates can each be found under the relevant field:
The public title has been updated. The previous title was: 'mEOC: A multicentre randomised Gynaecologic Cancer Intergroup (GCIG) trial comparing oxaliplatin plus capecitabine versus carboplatin plus paclitaxel in patients with previously untreated mucinous ovarian (mEOC) cancer '.
Additional exclusion criteria have been added.
The anticipated start date has been corrected. The original date was 01/11/2008.
The intervention section has been updated.

As of 22/08/2013 the anticipated end date was changed from 01/05/2015 to 01/12/2014.

Ethics approval

North West London Research Ethics Committee 2 on 29/10/2008 (ref: 08/H0720/106)

Study design

Phase III, multicentre, randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mucinous carcinoma of the ovary

Intervention

This is a phase III, multicentre, randomised controlled trial. This trial is not blinded due to different timings of administration of drugs between treatment arms.

Control arm: 6 cycles of chemotherapy with the following:
a. Carboplatin AUC 5 or AUC 6, intravenous (IV), given on day 1 (dose depends on method used to measure/ estimate glomerular filtration rate [GFR])
b. Paclitaxel 175 mg/m^2, IV, given on day 1

Research arm: 6 cycles of chemotherapy with the following:
a. Oxaliplatin 130 mg/m^2, IV, given on day 1
b. Capecitabine 850 mg/m^2 given twice per day, oral tablets, on the first 14 days of every 21 day cycle (total daily dose 1,700 mg/m^2)

Added 08/03/2011:
Bevacizumab 15 mg/kg IV given every 3 weeks for 5 or 6 cycles of chemotherapy. Followed by 12 cycles of Bevacizumab along given on day 1 every 3 weeks.

The total duration of follow-up is 5 years. Patients are seen every 3 months in years 1 and 2, and every 6 months in years 3-5. Computerised tomography (CT) or magnetic resonance imaging (MRI) scans are carried out 5 times in Year 1, every 6 months in year 2, and annually in years 3-5.

Previous interventions:
The total duration of follow-up is 5 years. Patients are seen every 3 months in years 1 and 2, and every 6 months in years 3-5. Computerised tomography (CT) or magnetic resonance imaging (MRI) scans are carried out every 6 months in years 1 and 2, and annually in years 3-5.

Intervention type

Drug

Phase

Phase III

Drug names

Oxaliplatin, capecitabine, carboplatin, paclitaxel

Primary outcome measures

Overall survival. Total duration of follow-up: 5 years.

Secondary outcome measures

1. Progression free survival. Total duration of follow-up: 5 years.
2. Response rate. Total duration of follow-up: 5 years.
3. Toxicity. Total duration of follow-up: 5 years.
4. Quality of life, measured using the Functional Assessment of Cancer Therapy - Ovarian module (FACT-O) Quality of Life assessment at baseline, after the third cycle of chemotherapy, 1 month after the final cycle of chemotherapy, then every 6 months throughout the five year follow-up period

Overall trial start date

21/01/2010

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Females, age >18 years
2. Histologically confirmed diagnosis of mucinous carcinoma of the ovary or fallopian tube
3. Federation of Obstetricians and Gynaecologists (FIGO) stage II-IV disease (no brain metastases)
4. Recurrent stage I disease (chemonaïve)
5. World Health Organization (WHO)-Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Life expectancy >3 months
7. Adequate bone marrow function
8. Adequate hepatic function
9. Adequate renal function
10. Adequate neurological function (sensory and motor neuropathy = grade 1, Common Terminology Criteria for Adverse Events [CTCAE] v4.0)
11. No previous chemotherapy
12. No evidence of primary carcinoma of the upper gastrointestinal tract
13. Patients who have signed an informed consent form
14. Adequate contraceptive precautions if relevant

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

330

Participant exclusion criteria

1. Histological epithelial non-mucinous cell types
2. Primary peritoneal carcinoma
3. Epithelial ovarian tumours of low malignant potential
4. Previous history of malignancy except cervical carcinoma in situ, and basal cell carcinoma of the skin
5. Presence of known brain metastases
6. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
7. Concurrent uncontrolled medical conditions
8. Previous chemotherapy, radiotherapy, or any investigational treatment for ovarian or rectal cancer
9. Pregnancy or breastfeeding
10. Clinically significant cardiac disease, symptomatic coronary artery disease and cardiac arryhthmia or myocardial infarction in the last 12 months
11. Patients with any symptoms or history of peripheral neuropathy
12. Previous history of malabsorption or other conditions preventing oral treatment
Added 08/03/2011:
13. Patients with non healing wound, ulcer or bone fracture
14. History or evidence of thrombotic or haemorrhagic disorders
15. Patients taking warfarin
16. Uncontrolled hypertension
17. Previous CVA, TIA or SAH within 6 months prior to randomisation
18. Patient prescribed biphosphonates

Recruitment start date

21/01/2010

Recruitment end date

01/12/2014

Locations

Countries of recruitment

France, Germany, Italy, Norway, United Kingdom

Trial participating centre

Department of Medicine
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

c/o Dr Nick McNally
Assistant Director Clinical Trials
Joint UCLH and UCL Biomedical Research Unit
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 5DB
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK will provide funding for the UK trial sites. The sources of funding for non-UK sites have not yet been finalised as of 15/07/2008.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes