MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer (MITO-5)
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
carboplatin
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, elderly, weekly chemotherapy, first-line
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
Sites / Locations
- Ospedale Fatebenefratelli, U.O. di Oncologia
- Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
- Ospedale Cannizzaro
- Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
- Ospedale S. Massimo
- Ospedale Civile Umberto I, Day Hospital Oncoematologico
- Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
- Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
- Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
- Ospedale S. Giovanni Calibita Fatebenefratelli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SINGLE ARM
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate
Toxicity
assessed weekly
Secondary Outcome Measures
possible predictive factors of the geriatric ADL and IADL scales
Full Information
NCT ID
NCT00401674
First Posted
November 17, 2006
Last Updated
January 13, 2016
Sponsor
National Cancer Institute, Naples
1. Study Identification
Unique Protocol Identification Number
NCT00401674
Brief Title
MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer
Acronym
MITO-5
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer, elderly, weekly chemotherapy, first-line
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SINGLE ARM
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
6 month
Title
Toxicity
Description
assessed weekly
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
possible predictive factors of the geriatric ADL and IADL scales
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Pignata, M.D., Ph.D
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Fatebenefratelli, U.O. di Oncologia
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
City
Campobasso
State/Province
CB
ZIP/Postal Code
86100
Country
Italy
Facility Name
Ospedale Cannizzaro
City
Cannizzaro
State/Province
CT
Country
Italy
Facility Name
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
City
Mantova
State/Province
MN
ZIP/Postal Code
46100
Country
Italy
Facility Name
Ospedale S. Massimo
City
Penne
State/Province
PE
Country
Italy
Facility Name
Ospedale Civile Umberto I, Day Hospital Oncoematologico
City
Nocera Inferiore
State/Province
SA
ZIP/Postal Code
84014
Country
Italy
Facility Name
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
City
Vicenza
State/Province
VI
ZIP/Postal Code
36100
Country
Italy
Facility Name
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale S. Giovanni Calibita Fatebenefratelli
City
Roma
ZIP/Postal Code
00186
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
18243011
Citation
Pignata S, Breda E, Scambia G, Pisano C, Zagonel V, Lorusso D, Greggi S, De Vivo R, Ferrandina G, Gallo C, Perrone F. A phase II study of weekly carboplatin and paclitaxel as first-line treatment of elderly patients with advanced ovarian cancer. A Multicentre Italian Trial in Ovarian cancer (MITO-5) study. Crit Rev Oncol Hematol. 2008 Jun;66(3):229-36. doi: 10.1016/j.critrevonc.2007.12.005. Epub 2008 Feb 1.
Results Reference
result
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MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer
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