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Trial record 1 of 1 for:    MITO-8
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Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval (MITO-8)

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ClinicalTrials.gov Identifier: NCT00657878
Recruitment Status : Unknown
Verified October 2015 by National Cancer Institute, Naples.
Recruitment status was:  Active, not recruiting
First Posted : April 14, 2008
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Tracking Information
First Submitted Date  ICMJE April 8, 2008
First Posted Date  ICMJE April 14, 2008
Last Update Posted Date October 29, 2015
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
overall survival [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2008)
overall survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
  • progression free survival [ Time Frame: 18 months ]
  • changes in quality of life [ Time Frame: 9 months ]
    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 ]
  • worst grade toxicity for each patient [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2008)
  • progression free survival
  • quality of life [ Time Frame: at baseline and after 3rd and 6th cycles of chemotherapy ]
  • response rate [ Time Frame: after 3rd and 6th cycles of chemotherapy ]
  • toxicity [ Time Frame: at each cycle of chemotherapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: stealth liposomal doxorubicin
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: Topotecan
    • Drug: Gemcitabine
  • 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
    Interventions:
    • Drug: stealth liposomal doxorubicin
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: Topotecan
    • Drug: Gemcitabine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 28, 2015)
215
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2008)
250
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00657878
Other Study ID Numbers  ICMJE MITO-8
2008-001755-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party National Cancer Institute, Naples
Original Responsible Party Sandro Pignata, National Cancer Institute Naples
Current Study Sponsor  ICMJE National Cancer Institute, Naples
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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. University of Campania "Luigi Vanvitelli"
PRS Account National Cancer Institute, Naples
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP