| Descriptive Information Fields | |||||||||
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| Brief Title † | MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer | ||||||||
| Official Title † | Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-Line Chemotherapy for Elderly Patients With Ovarian Cancer. | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Objective response rate Toxicity |
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| Secondary Outcome Measure † | possible predictive factors of the geriatric ADL and IADL scales | ||||||||
| Condition † | Ovarian Cancer | ||||||||
| Intervention † | Drug: carboplatin Drug: paclitaxel |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 26 | ||||||||
| Start Date † | June 2003 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 70 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | Italy | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00401674 | ||||||||
| Organization ID | MITO-5 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Cancer Institute, Naples | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Cancer Institute, Naples | ||||||||
| Verification Date | November 2006 | ||||||||
| First Received Date † | November 17, 2006 | ||||||||
| Last Updated Date | December 14, 2006 | ||||||||
