Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003941

Trial Description

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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.

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Trial Acronym

MITO-8

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003941
  •   2012/11/23
  •   2008/04/08
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Secondary IDs

  •   2008-001755-22 
  •   NCT00657878  (clinicaltrials.gov)
  •   MITO-8  (National Cancer Institute, Naples)
  •   2008-001755-22 
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Health Condition or Problem studied

  •   Ovarian Cancer
  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   Drug: stealth liposomal doxorubicin
  •   Drug: carboplatin
  •   Drug: paclitaxel
  •   Drug: Topotecan
  •   Drug: Gemcitabine
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Crossover
  •   III
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Primary Outcome

- overall survival; time frame: 18 months

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Belgium
  •   Germany
  •   Italy
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Locations of Recruitment

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Recruitment

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  •   2008/11/30
  •   250
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   no minimum age
  •   no maximum age
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Additional 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

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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

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Addresses

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    • National Cancer Institute, Naples
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    • National Cancer Institute, Naples
    • Sandro Pignata, M.D., Ph.D. 
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    • Marilina Piccirillo, M.D. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.