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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 17, 2006

Last Updated Date

February 3, 2009

Start Date ^†

June 2003

Current Primary Outcome Measures ^†

Objective response rate
Toxicity

Original Primary Outcome Measures ^†

Objective response rate
Toxicity

Change History

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

Current Secondary Outcome Measures ^†

possible predictive factors of the geriatric ADL and IADL scales

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Condition ^†

Ovarian Cancer

Intervention ^†

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 ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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

Eligibility 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

Gender

Female

Ages

70 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00401674

Responsible Party

Francesco Perrone, NCI Naples

Secondary IDs ^††

Study Sponsor ^†

National Cancer Institute, Naples

Collaborators ^††

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

Information Provided By

National Cancer Institute, Naples

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.