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

Ovarian Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00657878
• Other study ID #: MITO-8
• Secondary ID: 2008-001755-22
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2008
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 215
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Recurrence

Intervention

Drug:
• stealth liposomal doxorubicin
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
• carboplatin
carboplatin AUC 5 IV day 1 every 21 days
• paclitaxel
paclitaxel 175 mg/m2 IV day 1 every 21 days
• Topotecan
dosing and schedule according to Institutional guidelines
• Gemcitabine
1000 mg/m2 on days 1,8,15 every 28 days

Locations

Country	Name	City	State
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Gasthusiberg	Leuven
Belgium	CHC-Clinique St-Joseph	Liège
Belgium	Clinique & Maternité Sainte-Elisabeth	Namur
Belgium	AZ Nikolaas	Sint Niklaas
Germany	Charité Campus Virchow-Klinkum	Berlin
Germany	Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft	Essen
Germany	Universitatsklinikum	Essen
Germany	Universitatsklinikum	Freiburg
Germany	Gynecology, Albertinen Krankenhaus	Hamburg
Germany	Universitatskilinikum Schleswig-Holstein	Kiel
Germany	Frauenklinik	Marburg
Germany	Klinikum rechts der Isar der Technischen Universitat	Munchen
Italy	Ospedale Mazzoni	Ascoli Piceno
Italy	Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C	Aviano	PN
Italy	Policlinico Universitario	Bari
Italy	Universita di Bari Policinico I Clinical Ostetrica e Ginecologica	Bari
Italy	Ospedale Fatebenefratelli	Benevento
Italy	Ospedale Senatore Antonio Perrino	Brindisi
Italy	Universita Cattolica del Sacro Cuore	Campobasso
Italy	Ospedale Renzetti di Lanciano	Lanciano
Italy	Ospedale A. Manzoni	Lecco
Italy	Istituto Romagnolo per lo Studio e la Cura dei Tumori	Meldola
Italy	Istituto Europeo di Oncologia	Milano
Italy	Ospedale San Raffaele	Milano
Italy	Ospedale S. Gerardo	Monza
Italy	Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico	Napoli
Italy	Azienda Ospedaliera V. Cervello	Palermo	PA
Italy	Ospedale S. Massimo, Day Hospital Oncologico	Penne	PE
Italy	Ospedale Silvestrini	Perugia
Italy	Ospedale Civile S. Spirito	Pescara
Italy	A.O. Bianchi Melacrino Morelli Ospedale Riuniti	Reggio Calabria
Italy	Arcispedale S. Maria Nuova	Reggio Emilia
Italy	Ospedale degli Infermi, U.O. Oncologia Medica	Rimini
Italy	Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia	Roma
Italy	Universita Cattolica del Sacro Cuore	Roma
Italy	A.O. Ordine Mauriziano	Torino
Italy	Ospedale S. Chiara	Trento
Italy	A.O. di Udine S. Maria della Misericordia	Udine
Italy	Ospedale Del Ponte	Varese

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Countries where clinical trial is conducted

Belgium,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		18 months
Secondary	progression free survival		18 months
Secondary	changes in quality of life	quality of life is measured at baseline and at 3 months and 6 months after patient begins study	9 months
Secondary	number of objective responses		6 months
Secondary	worst grade toxicity for each patient		6 months