A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT02026921|
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : January 3, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Epithelial Cancer Recurrent||Drug: Carboplatin Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||December 2008|
Experimental: Carboplatin and docetaxel
Intravenous infusion every 3 weeks Carboplatin plus docetaxel
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
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.
Other Name: Taxotere
- Safety [ Time Frame: Up to 30 days after last chemotherapy course ]Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 2.0). All toxicities observed within 30 dayes of last chemocourse will be included.
- Response rate [ Time Frame: Up to 30 dayes after last chemotherapy course ]Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR.
- Progression free survival [ Time Frame: Up to 3 year ]Time from start of treatment to the earlier date of assessment of progression or death by any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026921
|Aalborg University Hospital|
|Aalborg, Denmark, 9000|
|Herlev University Hospital|
|Copenhagen, Denmark, 2730|
|Tampere University Hospital|
|Norwegian Radium Hospital|
|Oslo, Norway, 0310|
|Study Chair:||Gunnar B Kristensen, MD, PhD||NSGO-CTU|