Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin (ROLANDO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03161132|
Recruitment Status : Active, not recruiting
First Posted : May 19, 2017
Last Update Posted : April 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Ovarian Cancer||Drug: Olaparib Drug: Pegylated Liposomal Doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multicentric|
|Masking:||None (Open Label)|
|Official Title:||Multicentric Single Arm Phase II Clinical Trial, to Evaluate Safety and Efficacy of the Combination of Olaparib and PLD for Platinum Resistant Ovarian Primary Peritoneal Carcinoma, and Fallopian Tube Cancer Patients.|
|Actual Study Start Date :||December 13, 2017|
|Actual Primary Completion Date :||February 7, 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Olaparib 300mg
Olaparib bid orally at 300 mg (tablet formulation) continuously, combined with chemotherapy with Pegylated Liposomal Doxorubicin (up to 6 cycles), then, as monotherapy at the same dose and frequency (300mg bid orally) until progression of disease or unaccepted toxicity.
Combination of continous olaparib 300mg for oral administration plus Pegylated Liposomal Doxorubicin (PLD), followed by maintenance treatment further described.
Other Name: Lynparza
Pegylated Liposomal Doxorubicin (PLD)
PLD 40mg/m2 every 28 days intravenous for up to 6 cycles. This treatment will be combined with Olaparib (as described earlier).
Drug: Pegylated Liposomal Doxorubicin
PLD 40mg/m2 every 28 days intravenous
Other Name: PLD
- Progression-free Survival [ Time Frame: 6 months ]Proportion of pacients with no progression of disease at 6 months after start of treatment with Olaparib plus PLD
- Objective Response Rate [ Time Frame: 20 months ]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.
- Disease Control Rate [ Time Frame: 20 months ]Proportion of patients who have achieved complete response, partial response and stable disease of 8 or more months according to RECIST 1.1
- Response to treatment Rate according CA-125 levels [ Time Frame: 20 months ]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.
- Progression-free survival [ Time Frame: 20 months ]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.
- Overall survival [ Time Frame: 20 months ]Time from inclusion until death of any cause.
- Health related quality of life [ Time Frame: 20 months ]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.
- Activity of tumor based on the growth modulation index (GMI) [ Time Frame: 20 months ]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.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 20 months ]Frequency, nature and number of patients developing adverse events throughout follow up
- DNA damage [ Time Frame: 20 months ]BRCA pathway and defects in homologous recombination repair (HRR) Phosphorylation of γH2AX as a marker of DNA damage.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161132
|Corporación Sanitaria Parc Taulí|
|Sabadell, Barcelona, Spain|
|Hospital Universitario de Gran Canaria Doctor Negrín|
|Palmas de Gran Canaria, Gran Canaria, Spain|
|Hospital Son Llatzer|
|Palma De Mallorca, Mallorca, Spain|
|Hospital Universitario Ramón y Cajal|
|Madrid, Spain, 28034|
|Hospital Universitario 12 de Octubre|
|Hospital Universitario Virgen del Rocío|
|Hospital Universitario y Politécnico La Fe|
|Valencia, Spain, 46009|
|Hospital Clínico Universitario de Valencia|
|Study Director:||Alejandro Pérez-Fidalgo, M.D., Ph.D.||University of Valencia, Hospital Clinico Universitario de Valencia|