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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001999-10 | EudraCT Number |
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The purpose of this study is to determine the efficacy and the safety of the association of carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive to platin.
In front of a shortage of Caelyx, the implementation of an alternative treatment must be considered to treat patients with ovarian cancer in relapse, sensitive to platin: associate the carboplatin with another drug of the family of the doxorubicin: liposomal doxorubicin (Myocet®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carboplatin and liposomal doxorubicin | Experimental | carboplatin and liposomal doxorubicin in ovarian cancer in realapse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin and liposomal doxorubicin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the control disease rate in 1 year | 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the rate of objective answer (CR/PR) |
| 2,5 years |
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Inclusion Criteria:
First or second relapse of a carcinoma of the ovary, the fallopian tubes or the peritoneal tissue histological proved.
Interval without progress > 6 months after the last administration of a salt of platinum(deck).
Measurable Disease (according to the criteria RECIST 1.1) or an assessable disease according to CA-125 (according to the criteria of the GCIG).
Satisfactory biological Balance sheet(Assessment), according to the following criteria:
Performance status < 2.
Life expectancy of at least 12 weeks.
Age > 18 years.
Capacity to follow the protocol.
Consent signed before any procedure of inclusion.
Membership in a national insurance scheme.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles FREYER, Dr | Hospices Civiles de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Radiothérapie et d'Oncologie | Agen | France | ||||
| Centre Paul Papin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30446275 | Derived | Romeo C, Joly F, Ray-Coquard I, El Kouri C, Mercier-Blas A, Berton-Rigaud D, Kalbacher E, Cojocarasu O, Fabbro M, Cretin J, Zannetti A, Abadie-Lacourtoisie S, Mollon D, Hardy-Bessard AC, Provansal M, Blot E, Delbaldo C, Lesoin A, Freyer G, You B. Non-pegylated liposomal doxorubicin (NPLD, Myocet(R)) + carboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial. Gynecol Oncol. 2019 Jan;152(1):68-75. doi: 10.1016/j.ygyno.2018.10.043. Epub 2018 Nov 14. |
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|
| Angers |
| France |
| Hôpital jean Minjoz | Besançon | France |
| Clinique Tivoli | Bordeaux | France |
| Institut Bergonié | Bordeaux | France |
| Hôpital Morvan - Centre Hospitalier Universitaire | Brest | 29200 | France |
| Centre François Baclesse | Caen | France |
| Centre Hospitalier de Cholet | Cholet | France |
| Centre Jean Perrin | Clermont-Ferrand | France |
| Centre Hospitalier Départemental Les Oudairies | La Roche-sur-Yon | France |
| Hôpital André Mignot | Le Chesnay | France |
| Centre Hospitalier du Mans | Le Mans | France |
| Centre Oscar Lambret | Lille | France |
| CHU Dupuytren | Limoges | France |
| Hopital de Scorff | Lorient | France |
| Centre Léon bérard | Lyon | France |
| Hopital privé Jean Mermoz | Lyon | France |
| Institut Paoli Calmettes | Marseille | France |
| Hôpital de Mont-de-Marsan | Mont-de-Marsan | France |
| ICM Val d'Aurelle | Montpellier | France |
| Centre Azuréen de Cancérologie | Mougins | France |
| Centre Catherine de Sienne | Nantes | France |
| Polyclinique KENVAL - Site de Valdegour | Nîmes | France |
| Centre Hospitalier Régional d'Orléans | Orléans | France |
| Groupe Hospitalier Saint-Joseph | Paris | France |
| Hopital des Diaconesses | Paris | France |
| Centre Hospitalier Général de Pau | PAU Universite | France |
| Clinique Francheville | Périgueux | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | France |
| Centre Hospitalier de la Région d'Annecy | Pringy | France |
| Centre intercommunal de Quimper | Quimper | France |
| Institut Jean Godinot | Reims | France |
| Clinique Armoricaine | Saint-Brieuc | 22015 | France |
| Centre hospitalier privé de Saint Grégoire | Saint-Grégoire | France |
| ICO René Gauducheau | Saint-Herblain | France |
| Clinique Mutualiste de l'Estuaire | Saint-Nazaire | France |
| Institut cancérologuie de la loire | Saint-Priest-en-Jarez | France |
| Centre de Radiothérapie - Clinique Sainte-Anne | Strasbourg | 67000 | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | France |
| Centre Hospitalier General de Valenciennes | Valenciennes | France |
| Centre d'oncologie Saint-Yves | Vannes | France |
| Centre Hospitalier Bretagne Atlantique | Vannes | France |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C506643 | liposomal doxorubicin |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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