Trial Title:
Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
NCT ID:
NCT00657878
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Recurrence
Paclitaxel
Carboplatin
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Topotecan
Conditions: Keywords:
platinum free interval
chemotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
stealth liposomal doxorubicin
Description:
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
Arm group label:
non platinum based chemotherapy
Arm group label:
platinum based chemotherapy
Intervention type:
Drug
Intervention name:
carboplatin
Description:
carboplatin AUC 5 IV day 1 every 21 days
Arm group label:
non platinum based chemotherapy
Arm group label:
platinum based chemotherapy
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
paclitaxel 175 mg/m2 IV day 1 every 21 days
Arm group label:
non platinum based chemotherapy
Arm group label:
platinum based chemotherapy
Intervention type:
Drug
Intervention name:
Topotecan
Description:
dosing and schedule according to Institutional guidelines
Arm group label:
non platinum based chemotherapy
Arm group label:
platinum based chemotherapy
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
1000 mg/m2 on days 1,8,15 every 28 days
Arm group label:
non platinum based chemotherapy
Arm group label:
platinum based chemotherapy
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.
Criteria for 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
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AZ Groeninge
Address:
City:
Kortrijk
Country:
Belgium
Facility:
Name:
UZ Gasthusiberg
Address:
City:
Leuven
Country:
Belgium
Facility:
Name:
CHC-Clinique St-Joseph
Address:
City:
Liège
Country:
Belgium
Facility:
Name:
Clinique & Maternité Sainte-Elisabeth
Address:
City:
Namur
Country:
Belgium
Facility:
Name:
AZ Nikolaas
Address:
City:
Sint Niklaas
Country:
Belgium
Facility:
Name:
Charité Campus Virchow-Klinkum
Address:
City:
Berlin
Country:
Germany
Facility:
Name:
Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft
Address:
City:
Essen
Country:
Germany
Facility:
Name:
Universitatsklinikum
Address:
City:
Essen
Country:
Germany
Facility:
Name:
Universitatsklinikum
Address:
City:
Freiburg
Country:
Germany
Facility:
Name:
Gynecology, Albertinen Krankenhaus
Address:
City:
Hamburg
Country:
Germany
Facility:
Name:
Universitatskilinikum Schleswig-Holstein
Address:
City:
Kiel
Country:
Germany
Facility:
Name:
Frauenklinik
Address:
City:
Marburg
Country:
Germany
Facility:
Name:
Klinikum rechts der Isar der Technischen Universitat
Address:
City:
Munchen
Country:
Germany
Facility:
Name:
Azienda Ospedaliera V. Cervello
Address:
City:
Palermo
Country:
Italy
Facility:
Name:
Ospedale S. Massimo, Day Hospital Oncologico
Address:
City:
Penne
Zip:
65017
Country:
Italy
Facility:
Name:
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Facility:
Name:
Ospedale Mazzoni
Address:
City:
Ascoli Piceno
Country:
Italy
Facility:
Name:
Policlinico Universitario
Address:
City:
Bari
Country:
Italy
Facility:
Name:
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
Address:
City:
Bari
Country:
Italy
Facility:
Name:
Ospedale Fatebenefratelli
Address:
City:
Benevento
Country:
Italy
Facility:
Name:
Ospedale Senatore Antonio Perrino
Address:
City:
Brindisi
Country:
Italy
Facility:
Name:
Universita Cattolica del Sacro Cuore
Address:
City:
Campobasso
Country:
Italy
Facility:
Name:
Ospedale Renzetti di Lanciano
Address:
City:
Lanciano
Country:
Italy
Facility:
Name:
Ospedale A. Manzoni
Address:
City:
Lecco
Country:
Italy
Facility:
Name:
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Address:
City:
Meldola
Country:
Italy
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Country:
Italy
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Country:
Italy
Facility:
Name:
Ospedale S. Gerardo
Address:
City:
Monza
Country:
Italy
Facility:
Name:
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Ospedale Silvestrini
Address:
City:
Perugia
Country:
Italy
Facility:
Name:
Ospedale Civile S. Spirito
Address:
City:
Pescara
Country:
Italy
Facility:
Name:
A.O. Bianchi Melacrino Morelli Ospedale Riuniti
Address:
City:
Reggio Calabria
Country:
Italy
Facility:
Name:
Arcispedale S. Maria Nuova
Address:
City:
Reggio Emilia
Country:
Italy
Facility:
Name:
Ospedale degli Infermi, U.O. Oncologia Medica
Address:
City:
Rimini
Country:
Italy
Facility:
Name:
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
Address:
City:
Roma
Country:
Italy
Facility:
Name:
Universita Cattolica del Sacro Cuore
Address:
City:
Roma
Country:
Italy
Facility:
Name:
A.O. Ordine Mauriziano
Address:
City:
Torino
Country:
Italy
Facility:
Name:
Ospedale S. Chiara
Address:
City:
Trento
Country:
Italy
Facility:
Name:
A.O. di Udine S. Maria della Misericordia
Address:
City:
Udine
Country:
Italy
Facility:
Name:
Ospedale Del Ponte
Address:
City:
Varese
Country:
Italy
Start date:
November 2008
Completion date:
December 2023
Lead sponsor:
Agency:
National Cancer Institute, Naples
Agency class:
Other
Source:
National Cancer Institute, Naples
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00657878
