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

This study has been completed.

First Received on November 17, 2006. Last Updated on February 23, 2010 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

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:	26
Study Start Date:	June 2003
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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:	No

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
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
Campobasso, CB, Italy, 86100
Ospedale Cannizzaro
Cannizzaro, CT, Italy
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
Mantova, MN, Italy, 46100
Ospedale S. Massimo
Penne, PE, Italy
Ospedale Civile Umberto I, Day Hospital Oncoematologico
Nocera Inferiore, SA, Italy, 84014
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, Italy, 36100
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

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

No publications provided

Responsible Party:	Francesco Perrone, NCI Naples
ClinicalTrials.gov Identifier:	NCT00401674 History of Changes
Other Study ID Numbers:	MITO-5
Study First Received:	November 17, 2006
Last Updated:	February 23, 2010
Health Authority:	Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:

ovarian cancer
elderly
weekly chemotherapy
first-line

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012