Plain English Summary
http://www.cancerhelp.org.uk/trials/a-trial-chemotherapy-bevacizumab-mucinous-ovarian-cancer-meoc
Study website
Contact information
Type
Scientific
Contact name
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/CTIS number
2008-000837-23
IRAS number
ClinicalTrials.gov number
NCT01081262
Protocol/serial number
UCL/07/095
Study information
Scientific title
A GCIG Intergroup multicentre factorial trial of open label carboplatin and paclitaxel +/- bevacizumab compared with oxaliplatin and capecitabine +/- bevacizumab as first line chemotherapy in patients with mucinous Epithelial Ovarian Cancer (mEOC)
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.
Ethics approval(s)
North West London Research Ethics Committee 2, 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
Study setting(s)
Hospital
Study 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:
1. Carboplatin AUC 5 or AUC 6, intravenous (IV), given on day 1 (dose depends on method used to measure/ estimate glomerular filtration rate [GFR])
2. Paclitaxel 175 mg/m^2, IV, given on day 1
Research arm: 6 cycles of chemotherapy with the following:
1. Oxaliplatin 130 mg/m^2, IV, given on day 1
2. 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
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Oxaliplatin, capecitabine, carboplatin, paclitaxel
Primary outcome measure
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) 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 study start date
21/01/2010
Overall study end date
01/12/2014
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
330
Total final enrolment
50
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
England, France, Germany, Italy, Norway, United Kingdom
Study participating centre
Royal Marsden Hospital
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
England
United Kingdom
Sponsor type
University/education
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/06/2019 | 25/04/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |