Topic: National Cancer Research Network
Conditions
Interventions
Experimental arm:
Irinotecan 60 mg/m^2 intravenous (IV) on days 1, 8 and 15
Cisplatin 60 mg/m^2 IV on day 1
This combination is given every 4 weeks (28
Sponsors
Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with a histological diagnosis of clear cell carcinoma of the ovary, International Federation of Gynecology and Obstetrics (FIGO) stage I to IV. All patients must have have had a appropriate surgery for ovarian carcinoma with appropriate tissue available for histological evaluation. For patients participating in the trial from the UK, Central Pathology Review will take place prior to entry to confirm patients' eligibility. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 3. Reasonable organ function: must be assessed within 14 days of registration 4. Patients must have signed informed consent 5. Patients must be enrolled within 6 weeks of comprehensive surgery 6. Females aged over 18 years
Exclusion criteria
Exclusion criteria: 1. Patients with a current diagnosis of epithelial ovarian cancer of low malignant potential (borderline carcinomas) 2. Patients with a synchronous primary endometrial cancer, or a past history of primary endometrial cancer 3. Prior chemotherapy or radiation to treat the current disease 4. Patients who received intraperitoneal chemotherapy at time of operation 5. Prior diagnosis of malignancy (other than non-melanoma skin cancer or other malignancies curatively treated and greater than 5 years without evidence of recurrence) 6. Patients with diarrhoea greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 7. Patients who have received prior radiotherapy 8. Patients who have received prior chemotherapy 9. Patients with an active infection which requires antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival: patients are followed up clinically every 2 months until disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events: adverse event data will be collected during the treatment phase of the study 2. Overall survival: patients will be followed up at least until 36 months post-treatment 3. Response rate: to confirm best response to treatment, patients are scanned (computed tomography [CT]/magnetic resonance imaging [MRI]) pre-treatment | — |
Countries
France, Japan, Korea, South, Scotland, United Kingdom
Outcome results
None listed