Skip to main content
OpenTrials
Completed

NCT Number: NCT00401674

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale Fatebenefratelli, U.O. di Oncologia, Benevento, BN, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin

Drug

paclitaxel

Drug

Primary outcomes

  1. Objective response rate

    Time frame: 6 month

  2. Toxicity

    Time frame: up to 6 months

    assessed weekly

Secondary outcomes

  1. possible predictive factors of the geriatric ADL and IADL scales

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

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

Acronym: MITO-5

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Nov 20, 2006
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.