Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Approved-not yet active Not specified Other MITO-8 EudraCT number: 2008-001755-22, NCT00657878

Trial Description

Summary

This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval (PFI) 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.

Further Study Information

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 sequence of stealth liposomal doxorubicin followed at a later progression by carboplatin/paclitaxel is superior to the inverse sequence of treatment (carboplatin/paclitaxel followed at a later progression by stealth liposomal doxorubicin).

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 2

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute of Naples

Sandro Pignata, M.D., Ph.D.

Principal Investigator

Francesco Perrone, M.D., Ph.D.

Principal Investigator

Alessandro Morabito, M.D.,

Principal Investigator

Ciro Gallo, M.D., Ph.D.

Principal Investigator

Francesco Perrone, M.D., Ph.D.		Ph: +39 081 5903571
		Email: francesco.perrone@uosc.fondazionepascale.it

Sandro Pignata, M.D., Ph.D.		Ph: +39 081 5903637
		Email: sandro.pignata@uosc.fondazionepascale.it

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00657878
Information obtained from ClinicalTrials.gov on July 16, 2008