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

This study is ongoing, but not recruiting participants.

Sponsored by:	National Cancer Institute, Naples
Information provided by:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT00401674

Purpose

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

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

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.

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:

Objective response rate
Toxicity

Secondary Outcome Measures:

possible predictive factors of the geriatric ADL and IADL scales

Estimated Enrollment:

Study Start Date:

June 2003

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

Ages Eligible for Study:

70 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401674

Locations

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

Sponsors and Collaborators

National Cancer Institute, Naples

Investigators

Principal Investigator:	Sandro Pignata, M.D., Ph.D	National Cancer Institute, Naples
Principal Investigator:	Francesco Perrone, M.D., Ph.D	National Cancer Institute, Naples

More Information

Study ID Numbers:

MITO-5

First Received:

November 17, 2006

Last Updated:

December 14, 2006

ClinicalTrials.gov Identifier:

NCT00401674

Health Authority:

Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:

ovarian cancer
elderly
weekly chemotherapy
first-line

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 05, 2009