Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix

Phase 2

• Conditions: nonsquamous cell carcinoma of uterine cervix

• Registration Number: JPRN-UMIN000000564
• Lead Sponsor: Sankai Gynecology Study Group

Brief Summary

The response rate was 47.9% with 5 patients achieving complete response, 18 partial response, 14 stable disease, and 6 progressive disease. The disease control rate was 77.1%. With a median follow-up duration of 368 days, the median progression-free survival and overall survival were 6.1 months (95% CI 5.5-8.6) and 15.8 months (95% CI 18.2-28.3), respectively.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-01
• Study Completion: 2014-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1.Fever with over 38.0C 2.Infection or WBC>12,000/mm3 3.Severe complications 4.Neuropathy >Grade 2 5.Edema > Grade 2 6.Double cancer 7.Massive pleural effusion and ascites 8.Hypersensitivity reactions to docetaxel or carboplatin 9.Patients judged as exclusive case by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy

Secondary Outcome Measures

Name	Time	Method
Safety, Overall survival