A randomized international study testing the effect of prolonging platinum patients with ovarian cancer recurring between 6 and 12 months after previous platinum based chemotherapy on survival.

• Conditions: ovarian cancer recurrence; MedDRA version: 14.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-001755-22-BE
• Lead Sponsor: ational Cancer Institute Naples, Italy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-18
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

* Histological or cytological diagnosis of ovarian cancer
* Disease recurrence between 6 and 12 months after the end of the last cycle of a platinum based therapy
* Indication for chemotherapy, but no more than 2 previous lines of previous chemotherapy
* Life expectancy of more than 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 >=3
* Previous treatment with stealth liposomal doxorubicin
* Residual peripheral neuropathy >= Grade 3
* 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 >= 1.25 x normal values) or liver function (ALT or AST >= 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
*Concomitant participation in any other trial of systemic therapy or previous participation within 30 days before randomization
*Refusal of informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: * to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum 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.<br>* to evaluate if the sequence of non-platinum containing chemotherapy followed at progression by a platinum based chemotherapy is superior to the inverse sequence of treatment.<br>The primary endpoint is overall survival.;Secondary Objective: To compare both treatment arms for:<br>* progression free survival after the sequence<br>* Quality of life <br>* Overall response rate<br>* Overall treatment toxicity;Primary end point(s): * overall survival;Timepoint(s) of evaluation of this end point: Every 21 days during treatment and every 3 months during follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): * Progression free survival after the sequence (total PFS)<br>* Quality of life <br>* Overall response rate<br>* Overall treatment toxicity;Timepoint(s) of evaluation of this end point: NA