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
| ISRCTN | ISRCTN83438782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83438782 |
| EudraCT/CTIS number | 2008-000837-23 |
| ClinicalTrials.gov number | NCT01081262 |
| Secondary identifying numbers | UCL/07/095 |
- Submission date
- 15/07/2008
- Registration date
- 30/07/2008
- Last edited
- 25/04/2019
- 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.cancerhelp.org.uk/trials/a-trial-chemotherapy-bevacizumab-mucinous-ovarian-cancer-meoc
Contact information
Prof Martin Gore
Scientific
Scientific
Department of Medicine
Royal Marsden Hospital
Fulham Road
London
SW3 6JJ
United Kingdom
| Martin.Gore@rmh.nhs.uk |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Study acronym | mEOC |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 330 |
| Total final enrolment | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/01/2010 |
| Date of final enrolment | 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
SW3 6JJ
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
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
| Website | http://www.ucl.ac.uk |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
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.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
Editorial Notes
25/04/2019: Added clinicaltrials.gov link to basic results (scientific). Publication reference and total final enrolment added.
12/01/2017: No publications found, verifying study status with principal investigator.
22/08/2013: The overall trial end date was changed from 01/05/2015 to 01/12/2014.
08/03/2011: The following changes were made to the trial record:
1. The public title was 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 '.
2. The overall trial start date was changed from 01/11/2008 to 01/05/2015.
