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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00657878
First received: April 8, 2008
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: stealth liposomal doxorubicin
Drug: carboplatin
Drug: paclitaxel
Drug: Topotecan
Drug: Gemcitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • changes in quality of life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    quality of life is measured at baseline and at 3 months and 6 months after patient begins study

  • number of objective responses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • worst grade toxicity for each patient [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: November 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: non platinum based chemotherapy
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
Drug: stealth liposomal doxorubicin
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
Drug: carboplatin
carboplatin AUC 5 IV day 1 every 21 days
Drug: paclitaxel
paclitaxel 175 mg/m2 IV day 1 every 21 days
Drug: Topotecan
dosing and schedule according to Institutional guidelines
Drug: Gemcitabine
1000 mg/m2 on days 1,8,15 every 28 days
Active Comparator: platinum based chemotherapy
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
Drug: stealth liposomal doxorubicin
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days
Drug: carboplatin
carboplatin AUC 5 IV day 1 every 21 days
Drug: paclitaxel
paclitaxel 175 mg/m2 IV day 1 every 21 days
Drug: Topotecan
dosing and schedule according to Institutional guidelines
Drug: Gemcitabine
1000 mg/m2 on days 1,8,15 every 28 days

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657878

Contacts
Contact: Marilina Piccirillo, M.D. +39 081 5903615 marilina.piccirillo@usc-intnapoli.net
Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net

Locations
Belgium
AZ Groeninge Recruiting
Kortrijk, Belgium
UZ Gasthusiberg Recruiting
Leuven, Belgium
CHC-Clinique St-Joseph Recruiting
Liège, Belgium
Clinique & Maternité Sainte-Elisabeth Recruiting
Namur, Belgium
AZ Nikolaas Recruiting
Sint Niklaas, Belgium
Germany
Charité Campus Virchow-Klinkum Active, not recruiting
Berlin, Germany
Universitatsklinikum Active, not recruiting
Essen, Germany
Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft Active, not recruiting
Essen, Germany
Universitatsklinikum Active, not recruiting
Freiburg, Germany
Gynecology, Albertinen Krankenhaus Active, not recruiting
Hamburg, Germany
Universitatskilinikum Schleswig-Holstein Recruiting
Kiel, Germany
Frauenklinik Active, not recruiting
Marburg, Germany
Klinikum rechts der Isar der Technischen Universitat Active, not recruiting
Munchen, Germany
Italy
Azienda Ospedaliera V. Cervello Recruiting
Palermo, PA, Italy
Ospedale S. Massimo, Day Hospital Oncologico Recruiting
Penne, PE, Italy, 65017
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C Recruiting
Aviano, PN, Italy, 33081
Ospedale Mazzoni Recruiting
Ascoli Piceno, Italy
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica Recruiting
Bari, Italy
Policlinico Universitario Recruiting
Bari, Italy
Ospedale Fatebenefratelli Recruiting
Benevento, Italy
Ospedale Senatore Antonio Perrino Recruiting
Brindisi, Italy
Universita Cattolica del Sacro Cuore Recruiting
Campobasso, Italy
Ospedale Renzetti di Lanciano Recruiting
Lanciano, Italy
Ospedale A. Manzoni Recruiting
Lecco, Italy
Istituto Romagnolo per lo Studio e la Cura dei Tumori Recruiting
Meldola, Italy
Istituto Europeo di Oncologia Recruiting
Milano, Italy
Ospedale San Raffaele Recruiting
Milano, Italy
Ospedale S. Gerardo Recruiting
Monza, Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico Recruiting
Napoli, Italy, 80131
Ospedale Silvestrini Recruiting
Perugia, Italy
Ospedale Civile S. Spirito Recruiting
Pescara, Italy
A.O. Bianchi Melacrino Morelli Ospedale Riuniti Recruiting
Reggio Calabria, Italy
Arcispedale S. Maria Nuova Recruiting
Reggio Emilia, Italy
Ospedale degli Infermi, U.O. Oncologia Medica Recruiting
Rimini, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia Recruiting
Roma, Italy
Universita Cattolica del Sacro Cuore Recruiting
Roma, Italy
A.O. Ordine Mauriziano Recruiting
Torino, Italy
Ospedale S. Chiara Recruiting
Trento, Italy
A.O. di Udine S. Maria della Misericordia Recruiting
Udine, Italy
Ospedale Del Ponte Recruiting
Varese, Italy
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
Principal Investigator: Marilina Piccirillo, M.D. National Cancer Institute, Naples
Principal Investigator: Ciro Gallo, M.D., Ph.D. Second University of Naples
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00657878     History of Changes
Other Study ID Numbers: MITO-8, 2008-001755-22
Study First Received: April 8, 2008
Last Updated: February 20, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
platinum free interval
chemotherapy

Additional relevant MeSH terms:
Ovarian Neoplasms
Recurrence
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Disease Attributes
Pathologic Processes
Paclitaxel
Gemcitabine
Liposomal doxorubicin
Carboplatin
Doxorubicin
Topotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on October 02, 2014