Myocet ® - Carboplatine in Ovarian Cancer in Relapse, Sensitive to the Platinum (MYCA)
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|ClinicalTrials.gov Identifier: NCT01705158|
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: carboplatin and liposomal doxorubicin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||April 2017|
Experimental: carboplatin and liposomal doxorubicin
carboplatin and liposomal doxorubicin in ovarian cancer in realapse
Drug: carboplatin and liposomal doxorubicin
Carboplatin AUC5 and liposomal doxorubicin 40 or 50 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.
- Determine the control disease rate in 1 year [ Time Frame: 12 months ]To determine the proportion of not progressive patients in 1 year (rate of control of the disease or the rate of not progress in 12 months)
- To estimate the rate of objective answer (CR/PR) [ Time Frame: 2,5 years ]
- To estimate the survival without progress (PFS)
- To estimate the overal survival (OS)
- To estimate the profile of toxicity of the association.
- Quality of life.
- Validation of the clearance of CA-125 as predictive marker of the efficiency of the treatment and as factor forecast of the survival.
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): NCT01705158
|Principal Investigator:||Gilles FREYER, Dr||Hospices Civiles de Lyon|