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The purpose of this study is to evaluate activity and toxicity of the combination of carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or recurrent endometrial carcinoma.
Treatment is planned with carboplatin AUC 5 given IV on day 1 and liposomal doxorubicin 40 mg/m2 given IV on day 1, with treatment repeated every 28 days. Delays in treatment administration and dose reductions have been planned according to toxicity.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal doxorubicin | Drug | |||
| carboplatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (complete and partial responses) | ||
| Toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandro Pignata, M.D., Ph.D | National Cancer Institute, Naples | Principal Investigator |
| Francesco Perrone, M.D., Ph.D | National Cancer Institute, Naples | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Fatebenefratelli, U.O. di Oncologia | Benevento | BN | 82100 | Italy | ||
| Ospedale Pierantoni, Divisione di Oncologia Medica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17486128 | Result | Pignata S, Scambia G, Pisano C, Breda E, Di Maio M, Greggi S, Ferrandina G, Lorusso D, Zagonel V, Febbraro A, Riva N, De Rosa V, Gallo C, Perrone F; Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies Group. A multicentre phase II study of carboplatin plus pegylated liposomal doxorubicin as first-line chemotherapy for patients with advanced or recurrent endometrial carcinoma: the END-1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) group. Br J Cancer. 2007 Jun 4;96(11):1639-43. doi: 10.1038/sj.bjc.6603787. Epub 2007 May 8. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Forlì |
| FO |
| 47100 |
| Italy |
| Ospedale S. Giovanni Calibita Fatebenefratelli | Roma | Roma | 00186 | Italy |
| Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B | Naples | 80131 | Italy |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |