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MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer

Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.

NCT00401674•National Cancer Institute, Naples

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

70 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Age 70 years or greater
•Cytologic / histologic diagnosis ovarian cancer
•Stage of disease at diagnosis IC -IV
•Performance status (ECOG) \< 3
•Indication for chemotherapy treatment
•Written informed consent

Exclusion Criteria

•Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
•Cerebral metastases
•Neutrophils \< 1000/mm3, platelets \< 100000/mm3, hemoglobin \< 8g/dl
•Creatinine \> o = 1.25 times the upper normal limit
•GOT or GPT \> o = 1.25 times the upper normal limit, except in case of liver metastases)
•Patient's inability to comply with followup

Locations (10)

Ospedale Fatebenefratelli, U.O. di Oncologia

Benevento, BN, Italy

Università Cattolica del Sacro Cuore, Dipartimento di Oncologia

Campobasso, CB, Italy

Ospedale Cannizzaro

Cannizzaro, CT, Italy

Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia

Mantova, MN, Italy

Ospedale S. Massimo

Penne, PE, Italy

Ospedale S. Giovanni Calibita Fatebenefratelli

Roma, Roma, Italy

Ospedale Civile Umberto I, Day Hospital Oncoematologico

Nocera Inferiore, SA, Italy

Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica

Vicenza, VI, Italy

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Naples, Italy

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Naples, Italy

Key Dates

Start Date

June 1, 2003

Primary Completion Date

June 1, 2008

Completion Date

June 1, 2008

Last Updated

January 14, 2016

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

carboplatin

DRUG

paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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