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

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

Sponsor information

VU University Medical Center (The Netherlands)
Not defined

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

"ROR"	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