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
ISRCTN | ISRCTN30851756 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN30851756 |
Secondary identifying numbers | NTR471 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K. Hoekman
Scientific
Scientific
VU University Medical Center
Department of Medical Oncology
6 Z 170
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Study information
Study design | Multicentre, randomised, active controlled, parallel group trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | Doca-Cel |
Study objectives | To evaluate the antitumoural efficacy of celecoxib in combination with docetaxel/carboplatin in terms of: response rate, progression-free survival. The secondary objectives are: 1. To evaluate the safety and tolerability of this experimental treatment arm 2. To assess overall survival |
Ethics approval(s) | Received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Epithelial ovarian cancer, fallopian tube cancer, primary peritoneal carcinomas |
Intervention | Arm 1 (control arm): docetaxel 75 mg/m2 plus Carboplatin AUC 5, both intravenous (iv) on day 1, every 3 weeks, for 6-9 cycles. Arm 2: Docetaxel 75 mg/m2 plus Carboplatin AUC 5, both iv on day 1, every 3 weeks, for 6-9 cycles, together with celecoxib, 400 mg BID. Celecoxib will be continued for a maximum of 3 years or until progressive disease develops or until unacceptable toxicity occurs. In case docetaxel/carboplatin is permanently discontinued due to toxicity prior to course 4, celecoxib will be discontinued and patient goes off study. |
Intervention type | Other |
Primary outcome measure | 1. Response rate 2. Progression-free survival |
Secondary outcome measures | 1. Safety 2. Overall survival 3. Tolerability |
Overall study start date | 01/11/2002 |
Completion date | 01/12/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 200 |
Key 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. |
Key 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) |
Date of first enrolment | 01/11/2002 |
Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
VU University Medical Center (The Netherlands)
Not defined
Not defined
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
https://ror.org/00q6h8f30 |
Funders
Funder type
Hospital/treatment centre
VU University Medical Center (Netherlands)
No information available
Sanofi-Aventis (France)
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |