Impact of the combination of Olaparib and Pegylated Liposomal Doxorubicin on improvement of progression-free survival at 6 months in patients with platinum resistant advanced ovarian cancer.
The combination of Poly (ADP-ribose) polymerase (PARP) inhibitors with PLD may provide a synergistic effect in patients with advanced ovarian cancer, especially those with Homologous recombination deficiency (HRD), because of the decreased ability to repair chemotherapy-induced DNA damage. Preclinical studies with PARP inhibitors have shown potentiation of the cytotoxic effects of chemotherapeutic agents and a recent phase I study has shown the tolerability of the combination and efficacy in recurrent ovarian cancer. In this study, encouraging efficacy results were seen in ovarian cancer patients and were not limited by Germline BRCA1/2 (gBRCA) Mutations status or sensitivity to platinum therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Combination of continous olaparib 300mg for oral administration plus Pegylated Liposomal Doxorubicin (PLD), followed by maintenance treatment further described.
PLD 40mg/m2 every 28 days intravenous
Corporación Sanitaria Parc Taulí
Sabadell, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Son Llatzer
Palma de Mallorca, Mallorca, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Progression-free Survival
Proportion of pacients with no progression of disease at 6 months after start of treatment with Olaparib plus PLD
Time frame: 6 months
Objective Response Rate
Proportion of patients with tumor size reduction. Response duration is measured from the time of initial response until documented tumor progression. The Objective Response Rate (ORR) is defined as the sum of partial responses plus complete responses according to RECIST 1.1.
Time frame: 20 months
Disease Control Rate
Proportion of patients who have achieved complete response, partial response and stable disease of 8 or more months according to RECIST 1.1
Time frame: 20 months
Response to treatment Rate according CA-125 levels
Proportion of patients who have achieved a response according to CA-125: and it has occurred if there is at least a 50% reduction in CA-125 levels from a pretreatment sample.
Time frame: 20 months
Progression-free survival
Time from the date of the first dose of study treatment to the date of objective disease progression or death (in the absence of progression) regardless of whether the subject withdraws from study treatment or receives another anti-cancer therapy prior to progression.
Time frame: 20 months
Overall survival
Time from inclusion until death of any cause.
Time frame: 20 months
Health related quality of life
Change in patient's quality of life during the study, using the self-reported European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) and the EORTC ovarian cancer module (EORTC-OV-28). Both scores will be combined to report a final outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Time frame: 20 months
Activity of tumor based on the growth modulation index (GMI)
The GMI is the ratio of time to progression with the nth line (TTP(n)) of therapy to the TTP(n)(-1) with the n-1th line. GMI \>1.33 is considered as a sign of activity in phase II trials.
Time frame: 20 months