Condition category
Cancer
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr K. Hoekman

ORCID ID

Contact details

VU University Medical Center
Department of Medical Oncology
6 Z 170
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

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

Sponsor information

Organisation

VU University Medical Center (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes