Mucinous carcinoma of the ovary Cancer Malignant neoplasm of ovary
Conditions
Interventions
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 cyc
Sponsors
University College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival. Total duration of follow-up: 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France, Germany, Italy, Norway, United Kingdom
Outcome results
None listed