We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00401674
First Posted: November 20, 2006
Last Update Posted: January 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute, Naples
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Objective response rate [ Time Frame: 6 month ]
  • Toxicity [ Time Frame: up to 6 months ]
    assessed weekly


Secondary Outcome Measures:
  • possible predictive factors of the geriatric ADL and IADL scales [ Time Frame: 6 months ]

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)
Arms Assigned Interventions
Experimental: SINGLE ARM Drug: carboplatin Drug: paclitaxel

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00401674     History of Changes
Other Study ID Numbers: MITO-5
First Submitted: November 17, 2006
First Posted: November 20, 2006
Last Update Posted: January 14, 2016
Last Verified: January 2016

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
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action