INOVATYON SECOND LINE CHEMOTHERAPY OVARIAN CANCER
Research type
Research Study
Full title
Phase III international, randomized study of Trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum
IRAS ID
74423
Contact name
Ana Montes
Sponsor organisation
Mario Negri Institute
Eudract number
2010-022949-17
Clinicaltrials.gov Identifier
Research summary
Research Summary:
In the UK, the 5 year survival for ovarian cancer is 38%. At the time of presentation, 70% of women have advanced disease. Standard treatment consisting of surgery followed by platinum based chemotherapy achieves complete response in a large proportion of those patients, but most of them (80%) relapse within two years. Prognosis of patients at relapse is related to the platinum free interval (PFI), defined as the interval between the last platinum dose and the time of disease progression. If ovarian cancer re-appears more than six months after the last dose of platinum, the disease is considered platinum sensitive and is generally treated again with a platinum regimen. Within this group, there is a subgroup of intermediate or partial sensitivity; with PFI between 6 and 12 months with worse prognosis that the group whose disease progresses more than 12 months from last platinum dose. Platinum sensitive patients are conventionally treated with Carboplatin Paclitaxel after a trial (ICON4) demonstrated 5 month advantage in survival over Carboplatin alone. However, this combination was more toxic. More recently, other combinations have shown interesting activity. The CALYPSO study showed that Carboplatin and Pegylated liposomal doxorubicin (PLD) has similar activity and is less toxic than Carboplatin Paclitaxel. The OVA-301 study demonstrated that a new agent, Trabectedin; in combination with PLD is also active, especially in the partially platinum-sensitive subset.INOVATYON trial will investigate the role of a non-platinum combination (Trabectedin PLD) compared with the less toxic platinum combination, Carboplatin PLD for the treatment of ovarian cancer patients relapsing between 6 and 12 months after last platinum-based chemotherapy for whom there is need for new treatment options. Specifically, the present trial is aimed at demonstrating that extending the PFI with a non-platinum combination prolongs survival in patients with relapsed, partially platinum-sensitive ovarian cancer.Lay summary of study results:
Introduction In the INOVATYON study we wanted to determine if the combination of Trabectedin and Pegylated Lipo somal Doxorubicin (herein referred to as PLD) is better at improving overall survival than Carboplatin and PLD in patients in which ovarian cancer comes back between 6 and 12 months from the end of a last platinum-based chemotherapy.
There is a clinical need to find more active treatments for this group of patients This study tested the safety and effectiveness of a Trabectedin and PLD combination against Carboplatin and PLD. Both these drug regimens (Trabectedin plus PLD and Carboplatin plus PLD) have shown to be active and safe when used in relapsed ovarian cancer.REC name
London - Brent Research Ethics Committee
REC reference
11/LO/1261
Date of REC Opinion
4 Oct 2011
REC opinion
Further Information Favourable Opinion