Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR471
Study information
Scientific title
Acronym
Doca-Cel
Study hypothesis
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
Received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase II
Drug names
Primary outcome measures
1. Response rate
2. Progression-free survival
Secondary outcome measures
1. Safety
2. Overall survival
3. Tolerability
Overall trial start date
01/11/2002
Overall trial end date
01/12/2007
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant 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)
Recruitment start date
01/11/2002
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
VU University Medical Center (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanofi-Aventis (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary