NCT02026921

A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer

A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer. Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.

Detailed description

Evaluation of toxicity and response of treatment with carboplatin and docetaxel to patients with epithelial cancer of ovary, fallopian tube or peritoneum with their first relapse occurring at least 6 months after end of first line treatment- Evaluation of toxicity according to Clinical Toxicity Criteria version 2.

Conditions

• Ovarian Epithelial Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin, AUC5, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops
DRUG	Docetaxel	75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.

Timeline

• Start date: 2004-06-01
• Primary completion: 2006-03-01
• Completion: 2008-12-01
• First posted: 2014-01-03
• Last updated: 2014-01-03

Locations

4 sites across 3 countries: Denmark, Finland, Norway