Plain English Summary
Prof Martin Gore
Department of Medicine
Royal Marsden Hospital
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
4. Quality of life
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.
North West London Research Ethics Committee 2 on 29/10/2008 (ref: 08/H0720/106)
Phase III, multicentre, randomised controlled trial.
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Mucinous carcinoma of the ovary
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)
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.
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.
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
Overall trial end date
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
Target number of participants
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
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
Recruitment end date
Countries of recruitment
France, Germany, Italy, Norway, United Kingdom
Trial participating centre
Department of Medicine
University College London (UK)
c/o Dr Nick McNally
Assistant Director Clinical Trials
Joint UCLH and UCL Biomedical Research Unit
25 Grafton Way
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.
Funding Body Type
Funding Body Subtype
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