Effect of Celecoxib on reponse, progression-free and overall survival, when added to standaard first line chemotherapy in advanced ovarian cancer.

Completed

• Conditions: Ovarian Cancer; chemotherapy; celecoxib; fallopian tube; docetaxel; carboplatin; Cox-inhibitor; primary peritoneal cancer; FIGO stage 2-4; cytoreductive surgery

• Registration Number: NL-OMON23637
• Lead Sponsor: Sanofi-AventisPfizer

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Histologically confirmed epithelial ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer.

2.Age > 18 year

Exclusion Criteria

1.ECOG performance status. > 2

2.Prior treatment with chemotherapy or radiotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objectives of this randomized phase II study are:<br /><br>- To evaluate the antitumoral efficacy of celecoxib in combination with docetaxel/carboplatin in<br> terms of :<br /><br><br>a) Response rate (cCR, cPR)<br /><br>b) Progression-free survival (PFS)<br /><br><br>

Secondary Outcome Measures

Name	Time	Method
The secondary objectives of this randomized phase II study are:<br /><br><br>- To evaluate the safety and tolerability of this experimental treatment arm.<br /><br>-To assess overall survival<br /><br>