Epithelial ovarian cancer, ovarian fallopian tube or primary peritoneal carcinomas
Conditions
Interventions
Arm 1 (control arm):
Docetaxel 75 mg/m2 plus Carboplatin AUC 5, both i.v. on day 1, q 3 weeks, for 6-90 cycles.
Arm 2:
Docetaxel 75 mg/m2 plus Carboplatin AUC 5, both i.v. on day 1, q 3 weeks, fo
Sponsors
VU medical center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed epithelial ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer; 2. Age ¡Ý 18 year; 3. FIGO stages Ic-IV with or without successful cytorecductive surgery at staging laparotomy; 4. Written informed consent; 5. Can comply with follow-up requirements; 6. The subjects is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors. Chronic use of NSAIDs is defined as a frequency of 7 consecutive days (1 week) for > 3 weeks per year or more than 21 days throughout the year.
Exclusion criteria
Exclusion criteria: 1. ECOG performance status > 2. 2. Prior treatment with chemotherapy or radiotherapy. 3. More than 6 weeks between initial laparotomy/surgery and planned commencement of chemotherapy. 4. Patients with, pre-existing fluid retention such as pleural effusion, pericardial effusion and ascites are not excluded from the study, but should be monitored closely for any deterioration. Efforts should be made to determine by cytological analysis whether any significant pre-existing fluid collections are due to ovarian cancer, and subsequent drainage is recommended before initiating chemotherapy. 5. Inadequate bone marrow function defined as neutrophils upper limit of normal or AST/ALT >1.5 x upper limit of normal or ALP > 2.5 x upper limit of normal; 8. Concurrent severe and/or uncontrolled co-morbid medical condition (i.e. uncontrolled infection, hypertension, established ischaemic heart disease or cerebrovascular disease, congestive heart failure NYHA class II-IV, peripheral arterial disease); 9. Patients with mixed mesodermal tumours; 10. Patients with borderline ovarian tumours or tumours termed ¡®possibly malignant; 11. Adenocarcinoma of unknown origin, if histologically shown to be mucin-secreting cancer or if considered possibly to have a non-gynecological origin; 12. History of previous malignancy within the previous 5 years (except curatively treated carcinoma in situ of the uterine cervix, or basal cell carcinoma of the skin), or concurrent malignancy (e.g. co-existing endometrial cancer); 13. History of prior serious allergic reactions (e.g. anaphylactic shock); 14. Known hypersensitivity to sulphonamides; 15. Chronic use of NSAIDs, COX-2 inhibitors or Aspirin; 16. Symptomatic peripheral neuropathy > NCIC-CTC grade II; 17. Active peptic ulcer or gastrointestinal bleeding; 18. Inflammatory bowel disease, uncontrolled Cohn¡¯s disease or ulcerative colitis; 19. Unresolved bowel obstruction or sub-acute obstruction, current history of chronic diarrhea; 20. Pregnant or lactating women (or potentially fertile women not using adequate contraception).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate, progression-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, overall survival, tolerability. | — |
Contacts
Public ContactK. Hoekman
VU Medical Center Department of Medical Oncology 6 Z 170 P.O. Box 7057
Outcome results
None listed