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The purpose of this study is to evaluate the toxicity and activity of weekly administration of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian cancer stage IC-IV.
This is a phase II multicenter study. The experimental treatment is carboplatin (AUC 2) and paclitaxel 60 mg/m2, on days 1, 8 and 15 every 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SINGLE ARM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug |
| ||
| paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 6 month | |
| Toxicity | assessed weekly | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| possible predictive factors of the geriatric ADL and IADL scales | 6 months |
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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 | ||
| Università Cattolica del Sacro Cuore, Dipartimento di Oncologia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18243011 | Result | Pignata S, Breda E, Scambia G, Pisano C, Zagonel V, Lorusso D, Greggi S, De Vivo R, Ferrandina G, Gallo C, Perrone F. A phase II study of weekly carboplatin and paclitaxel as first-line treatment of elderly patients with advanced ovarian cancer. A Multicentre Italian Trial in Ovarian cancer (MITO-5) study. Crit Rev Oncol Hematol. 2008 Jun;66(3):229-36. doi: 10.1016/j.critrevonc.2007.12.005. Epub 2008 Feb 1. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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|
| Campobasso |
| CB |
| 86100 |
| Italy |
| Ospedale Cannizzaro | Cannizzaro | CT | Italy |
| Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia | Mantua | MN | 46100 | Italy |
| Ospedale S. Massimo | Penne | PE | Italy |
| Ospedale S. Giovanni Calibita Fatebenefratelli | Roma | Roma | 00186 | Italy |
| Ospedale Civile Umberto I, Day Hospital Oncoematologico | Nocera Inferiore | SA | 84014 | Italy |
| Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica | Vicenza | VI | 36100 | Italy |
| Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B | Naples | 80131 | Italy |
| Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C | Naples | 80131 | Italy |
| 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 |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |