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

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ClinicalTrials.gov Identifier: NCT00401674
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: carboplatin Drug: paclitaxel Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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.
Study Start Date : June 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SINGLE ARM Drug: carboplatin Drug: paclitaxel



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


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


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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

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

Publications of Results:
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00401674     History of Changes
Other Study ID Numbers: MITO-5
First Posted: November 20, 2006    Key Record Dates
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