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

Tracking Information

First Received Date ^ICMJE

November 17, 2006

Last Updated Date

February 3, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective response rate
Toxicity

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00401674 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

possible predictive factors of the geriatric ADL and IADL scales

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Ovarian Cancer

Intervention ^ICMJE

Drug: carboplatin
Drug: paclitaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

70 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00401674

Responsible Party

Francesco Perrone, NCI Naples

Study ID Numbers ^ICMJE

MITO-5

Study Sponsor ^ICMJE

National Cancer Institute, Naples

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute, Naples

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP