|- candidate number||4223|
|- NTR Number||NTR1491|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-okt-2008|
|- Secondary IDs||2002/241 METC UMCG |
|- Public Title||Effect of Celecoxib on reponse, progression-free and overall survival, when added to standaard first line chemotherapy in advanced ovarian cancer.|
|- Scientific Title||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
DoCa – Cel
|- hypothesis||Primairy Objectives: |
- To evaluate the antitumoral efficacy of celecoxib in combination with docetaxel/carboplatin in terms of:
a) response (cCR, cPR, NC, PD)
b) progression-free survival
-To evaluate the safety and tolerability of this experimental treatment arm.
-To assess Overall Survival
|- Healt Condition(s) or Problem(s) studied||Ovarian cancer, Fallopian tube cancer , Chemotherapy, COX-2 inhibitors, Celecoxib, Docetaxel, Carboplatin|
|- Inclusion criteria||1. Histologically confirmed epithelial ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer.|
2. Age > 18 year
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 109/l or platelets <100 x 109/l.
6. Inadequate renal function defined by a creatinin 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, ischaemic heart disease, myocardial infarction within previous 6 months, congestive heart failure).
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-gynaecological 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. Chronic use of NSAIDs, COX-2 inhibitors or Aspirin.
15. Symptomatic peripheral neuropathy > NCIC-CTC grade II.
16. Active peptic ulcer or gastrointestinal bleeding.
17. Inflammatory bowel disease, uncontrolled Crohn’s disease or ulcerative colitis.
18. Unresolved bowel obstruction or sub-acute obstruction, current history of chronic diarrhea.
19. Pregnant or lactating women (or potentially fertile women not using adequate contraception).
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2002|
|- planned closingdate||1-nov-2008|
|- Target number of participants||200|
|- Interventions||Oral Celecoxib 2 x 400 mg during and for 32 yrs after primary chemotherapy.|
|- Primary outcome||The primary objectives of this randomized phase II study are:|
- To evaluate the antitumoral efficacy of celecoxib in combination with docetaxel/carboplatin in
terms of :
a) Response rate (cCR, cPR)
b) Progression-free survival (PFS)
|- Secondary outcome||The secondary objectives of this randomized phase II study are:|
- To evaluate the safety and tolerability of this experimental treatment arm.
- To assess overall survival
|- Timepoints||Interim analysis after 2x75 pts for response|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. PHB Willemse|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. PHB Willemse|
|- Sponsor/Initiator ||VU University Medical Center, Department of Medical Oncology|
(Source(s) of Monetary or Material Support)
|- Brief summary||Effect of Celecoxib on reponse, progression-free and overall survival, when added to standaard first line chemotherapy in advanced ovarian cancer.|
|- Main changes (audit trail)||Added at inclusion:
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.
Intervention changed from: Oral Celecoxib during and after chemotherapy. TO: Oral Celecoxib 2 x 400 mg during and for 32 yrs after primary chemotherapy.
Contact changed to Prof Dr PHB Willemse, UMCG, Hanzeplein 1, 9700 RB Groningen, email@example.com;
|- RECORD||13-okt-2008 - 9-aug-2009|