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Sponsored by: |
National Cancer Institute, Naples |
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Information provided by: | National Cancer Institute, Naples |
ClinicalTrials.gov Identifier: | NCT00401674 |
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.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer |
Drug: carboplatin Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-Line Chemotherapy for Elderly Patients With Ovarian Cancer. |
Estimated Enrollment: | 26 |
Study Start Date: | June 2003 |
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.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B | |
Napoli, Italy, 80131 | |
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C | |
Napoli, Italy, 80131 | |
Ospedale S. Giovanni Calibita Fatebenefratelli | |
Roma, Italy, 00186 | |
Italy, BN | |
Ospedale Fatebenefratelli, U.O. di Oncologia | |
Benevento, BN, Italy, 82100 | |
Italy, CB | |
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia | |
Campobasso, CB, Italy, 86100 | |
Italy, CT | |
Ospedale Cannizzaro | |
Cannizzaro, CT, Italy | |
Italy, MN | |
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia | |
Mantova, MN, Italy, 46100 | |
Italy, PE | |
Ospedale S. Massimo | |
Penne, PE, Italy | |
Italy, SA | |
Ospedale Civile Umberto I, Day Hospital Oncoematologico | |
Nocera Inferiore, SA, Italy, 84014 | |
Italy, VI | |
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica | |
Vicenza, VI, Italy, 36100 |
Principal Investigator: | Sandro Pignata, M.D., Ph.D | National Cancer Institute, Naples |
Principal Investigator: | Francesco Perrone, M.D., Ph.D | National Cancer Institute, Naples |
Study ID Numbers: | MITO-5 |
Study First Received: | November 17, 2006 |
Last Updated: | December 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00401674 |
Health Authority: | Italy: Ethics Committee |
ovarian cancer elderly weekly chemotherapy first-line |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Paclitaxel Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Carboplatin Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions Adnexal Diseases |