Advanced ovarian cancer Cancer Malignant neoplasm of other and unspecified female genital organs
Conditions
Interventions
Patients will be randomised to receive EITHER Carboplatin flat dose (no dose escalation) OR Carboplatin with an intra-patient dose escalation scheme based on nadir blood counts. The dose of Carboplati
Sponsors
University of Glasgow (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current information as of 11/08/09: 1. Patients with histologically confirmed epithelial ovarian carcinoma, or primary fallopian tube carcinoma, considered unsuitable or unwilling for treatment with platinum-taxane combination therapy. Patients with peritoneal carcinomatosis (ovarian-type) are also eligible, without necessarily having histological proof of a primary source in the ovary, provided that the tumour is not mucin-secreting (see exclusion criteria). 2. Female, aged 18 or over. 3. FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy. Stage Ic patients will be limited to those with malignant cells in ascitic fluid/peritoneal washings, tumour on the surface of the ovary, or pre-operative capsule rupture. 4. Written informed consent 5. Can comply with follow up requirements 6. Intention to treat patient within 8 weeks of initial surgery. Initial information at time of registration: Patients with histologically confirmed epithelial ovarian carcinoma (stage IC - IV), or primary fallopian tube carcinoma, considered unsuitable or unwilling for treatment with platinum-taxane combination therapy
Exclusion criteria
Exclusion criteria: Added 11/08/09: 1. ECOG performance > 3 2. Prior treatment with chemotherapy and radiotherapy 3. Inadequate bone marrow function defined as neutrophils upper limit of normal or AST/ALT >2.5 x upper limit of normal or ALP > 5 x upper limit of normal. 6. Concurrent severe and/or uncontrolled co-morbid medical condition (i.e. uncontrolled infection, hypertension, ischaemic heart disease, myocardial infarction within previous 6 months, congestive heart failure) 7. Patient with mixed mesodermal tumours 8. Patients with boderline ovarian tumours or tumours termed "possibly malignant" 9. Adenocarcinoma of unknown origin, if histologically shown
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added 11/08/09: Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 11/08/09: 1. Toxicity 2. Quality of life 3. Response rates (clinical and CA125) 4. Overall survival | — |
Countries
United Kingdom
Outcome results
None listed