ISRCTN30851756CompletedNot Applicable
A randomized phase II study investigating the addition of the specific cox-2 inhibitor celecoxib to docetaxel plus carboplatin as first-line chemotherapy for stage IC-IV epithelial ovarian fallopian tube or primary peritoneal carcinomas
VU University Medical Center (The Netherlands)0 sites200 target enrollmentStarted: January 27, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Histologically confirmed epithelial ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer
- •2. Age >18 years
- •3. FIGO stages Ic-IV with or without successful cytoreductive surgery at staging laparotomy
- •4. Written informed consent
- •5. Can comply with follow-up requirements
- •6. The subject 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
- •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 <1.5 x 10^9/l or platelets <100 x 10^9/l
- •6. Inadequate renal function defined by a creatinine clearance <40 ml/min, calculated by the Cockcroft-Gault Formula
- •7. Inadequate liver function as defined by bilirubin > 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)
Investigators
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