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Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval (MITO-8)

Primary Purpose

Ovarian Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
stealth liposomal doxorubicin
carboplatin
paclitaxel
Topotecan
Gemcitabine
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring platinum free interval, chemotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological or cytological diagnosis of ovarian cancer
  • Disease recurrence between 6 and 12 months after a first-line platinum based therapy
  • Indication for chemotherapy, but no more than 2 previous lines of previous therapy
  • Life expectancy of more than 3 months

Exclusion Criteria:

  • Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix)
  • ECOG Performance Status at least 3
  • Previous treatment with stealth liposomal doxorubicin
  • Residual peripheral neuropathy Grade 3 or higher
  • Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
  • Neutrophils < 2000 x mm3, platelets < 100000 x mm3
  • Inadequate renal function (creatinine no greater than 1.25 x normal values) or liver function (ALT or AST no greater than 1.25 x normal values)
  • Present or suspected hemorrhagic syndromes
  • Inability to comply with protocol and follow-up
  • Inability to access study site for clinical visits
  • Refusal of informed consent

Sites / Locations

  • AZ Groeninge
  • UZ Gasthusiberg
  • CHC-Clinique St-Joseph
  • Clinique & Maternité Sainte-Elisabeth
  • AZ Nikolaas
  • Charité Campus Virchow-Klinkum
  • Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft
  • Universitatsklinikum
  • Universitatsklinikum
  • Gynecology, Albertinen Krankenhaus
  • Universitatskilinikum Schleswig-Holstein
  • Frauenklinik
  • Klinikum rechts der Isar der Technischen Universitat
  • Azienda Ospedaliera V. Cervello
  • Ospedale S. Massimo, Day Hospital Oncologico
  • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
  • Ospedale Mazzoni
  • Policlinico Universitario
  • Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
  • Ospedale Fatebenefratelli
  • Ospedale Senatore Antonio Perrino
  • Universita Cattolica del Sacro Cuore
  • Ospedale Renzetti di Lanciano
  • Ospedale A. Manzoni
  • Istituto Romagnolo per lo Studio e la Cura dei Tumori
  • Istituto Europeo di Oncologia
  • Ospedale San Raffaele
  • Ospedale S. Gerardo
  • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
  • Ospedale Silvestrini
  • Ospedale Civile S. Spirito
  • A.O. Bianchi Melacrino Morelli Ospedale Riuniti
  • Arcispedale S. Maria Nuova
  • Ospedale degli Infermi, U.O. Oncologia Medica
  • Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
  • Universita Cattolica del Sacro Cuore
  • A.O. Ordine Mauriziano
  • Ospedale S. Chiara
  • A.O. di Udine S. Maria della Misericordia
  • Ospedale Del Ponte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

non platinum based chemotherapy

platinum based chemotherapy

Arm Description

a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression

platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

progression free survival
changes in quality of life
quality of life is measured at baseline and at 3 months and 6 months after patient begins study
number of objective responses
worst grade toxicity for each patient

Full Information

First Posted
April 8, 2008
Last Updated
March 23, 2023
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00657878
Brief Title
Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
Acronym
MITO-8
Official Title
Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.
Detailed Description
Ovarian cancer is the most deadly gynecologic cancer. Though many patients respond well initially to chemotherapy, most of them in time will suffer a relapse. Patients often receive multiple lines of chemotherapy for their recurrences, and the choice of chemotherapy depends largely on the time interval since the last therapy. Patients whose disease recurs longer than 12 months after a platinum containing treatment are considered to be platinum sensitive, and are candidates for retreatment with a platinum regimen. Patients in whom disease recurs less than 6 months after a platinum containing treatment are considered platinum resistant or refractory, and are treated with a non platinum chemotherapy. The option of treatment is less clear for patients whose disease recurs between 6 and 12 months after platinum containing therapy. It is hypothesized that prolonging the interval since last platinum treatment by using a non platinum chemotherapy will result in better outcomes for these patients. This study will evaluate if the experimental sequence of a non platinum based chemotherapy, followed at a later progression by a platinum based chemotherapy is superior, in terms of the effect on overall survival, to the standard inverse sequence of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
platinum free interval, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non platinum based chemotherapy
Arm Type
Experimental
Arm Description
a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression
Arm Title
platinum based chemotherapy
Arm Type
Active Comparator
Arm Description
platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression
Intervention Type
Drug
Intervention Name(s)
stealth liposomal doxorubicin
Intervention Description
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
carboplatin AUC 5 IV day 1 every 21 days
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
paclitaxel 175 mg/m2 IV day 1 every 21 days
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
dosing and schedule according to Institutional guidelines
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1000 mg/m2 on days 1,8,15 every 28 days
Primary Outcome Measure Information:
Title
overall survival
Time Frame
18 months
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
18 months
Title
changes in quality of life
Description
quality of life is measured at baseline and at 3 months and 6 months after patient begins study
Time Frame
9 months
Title
number of objective responses
Time Frame
6 months
Title
worst grade toxicity for each patient
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological or cytological diagnosis of ovarian cancer Disease recurrence between 6 and 12 months after a first-line platinum based therapy Indication for chemotherapy, but no more than 2 previous lines of previous therapy Life expectancy of more than 3 months Exclusion Criteria: Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix) ECOG Performance Status at least 3 Previous treatment with stealth liposomal doxorubicin Residual peripheral neuropathy Grade 3 or higher Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias) Neutrophils < 2000 x mm3, platelets < 100000 x mm3 Inadequate renal function (creatinine no greater than 1.25 x normal values) or liver function (ALT or AST no greater than 1.25 x normal values) Present or suspected hemorrhagic syndromes Inability to comply with protocol and follow-up Inability to access study site for clinical visits Refusal of informed consent
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
First Name & Middle Initial & Last Name & Degree
Marilina Piccirillo, M.D.
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ciro Gallo, M.D., Ph.D.
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Groeninge
City
Kortrijk
Country
Belgium
Facility Name
UZ Gasthusiberg
City
Leuven
Country
Belgium
Facility Name
CHC-Clinique St-Joseph
City
Liège
Country
Belgium
Facility Name
Clinique & Maternité Sainte-Elisabeth
City
Namur
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint Niklaas
Country
Belgium
Facility Name
Charité Campus Virchow-Klinkum
City
Berlin
Country
Germany
Facility Name
Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft
City
Essen
Country
Germany
Facility Name
Universitatsklinikum
City
Essen
Country
Germany
Facility Name
Universitatsklinikum
City
Freiburg
Country
Germany
Facility Name
Gynecology, Albertinen Krankenhaus
City
Hamburg
Country
Germany
Facility Name
Universitatskilinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
Frauenklinik
City
Marburg
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitat
City
Munchen
Country
Germany
Facility Name
Azienda Ospedaliera V. Cervello
City
Palermo
State/Province
PA
Country
Italy
Facility Name
Ospedale S. Massimo, Day Hospital Oncologico
City
Penne
State/Province
PE
ZIP/Postal Code
65017
Country
Italy
Facility Name
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedale Mazzoni
City
Ascoli Piceno
Country
Italy
Facility Name
Policlinico Universitario
City
Bari
Country
Italy
Facility Name
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
City
Bari
Country
Italy
Facility Name
Ospedale Fatebenefratelli
City
Benevento
Country
Italy
Facility Name
Ospedale Senatore Antonio Perrino
City
Brindisi
Country
Italy
Facility Name
Universita Cattolica del Sacro Cuore
City
Campobasso
Country
Italy
Facility Name
Ospedale Renzetti di Lanciano
City
Lanciano
Country
Italy
Facility Name
Ospedale A. Manzoni
City
Lecco
Country
Italy
Facility Name
Istituto Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
Ospedale S. Gerardo
City
Monza
Country
Italy
Facility Name
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Silvestrini
City
Perugia
Country
Italy
Facility Name
Ospedale Civile S. Spirito
City
Pescara
Country
Italy
Facility Name
A.O. Bianchi Melacrino Morelli Ospedale Riuniti
City
Reggio Calabria
Country
Italy
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Ospedale degli Infermi, U.O. Oncologia Medica
City
Rimini
Country
Italy
Facility Name
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
City
Roma
Country
Italy
Facility Name
Universita Cattolica del Sacro Cuore
City
Roma
Country
Italy
Facility Name
A.O. Ordine Mauriziano
City
Torino
Country
Italy
Facility Name
Ospedale S. Chiara
City
Trento
Country
Italy
Facility Name
A.O. di Udine S. Maria della Misericordia
City
Udine
Country
Italy
Facility Name
Ospedale Del Ponte
City
Varese
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
29462248
Citation
Piccirillo MC, Scambia G, Bologna A, Signoriello S, Vergote I, Baumann K, Lorusso D, Murgia V, Sorio R, Ferrandina G, Sacco C, Cormio G, Breda E, Cinieri S, Natale D, Mangili G, Pisano C, Cecere SC, Di Napoli M, Salutari V, Raspagliesi F, Arenare L, Bergamini A, Bryce J, Daniele G, Gallo C, Pignata S, Perrone F. Quality-of-life analysis of the MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study comparing platinum-based versus non-platinum-based chemotherapy in patients with partially platinum-sensitive recurrent ovarian cancer. Ann Oncol. 2018 May 1;29(5):1189-1194. doi: 10.1093/annonc/mdy062.
Results Reference
derived

Learn more about this trial

Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval

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