Overview

This trial is active, not recruiting.

Condition ovarian epithelial cancer recurrent
Treatment trabectedin and pegylated liposomal doxorubicin
Sponsor Grupo Español de Investigación en Cáncer de Ovario
Collaborator PharmaMar
Start date March 2015
End date December 2016
Trial size 80 participants
Trial identifier NCT02394015, GEI-TRAB-2014-01, GEICO 1402R

Summary

Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective
Arm
Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC.
trabectedin and pegylated liposomal doxorubicin
Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC from October 28, 2009 to October 31, 2014

Primary Outcomes

Measure
Efficacy progression-free survival (PFS)
time frame: Up to 12 months
Overall survival (OS)
time frame: Up to 12 months

Secondary Outcomes

Measure
Response rate to previous and post-treatment (Percentage of responses (CR+PR)
time frame: Up to 12 months
Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)
time frame: Up to 12 months
Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD)
time frame: Up to 12 months
Impact of trabectedin - PLD combination in subsequent treatments
time frame: Up to 12 months
Toxicity (adverse events)
time frame: Up to 12 months
Comparison between PFS and PFS2
time frame: Up to 12 months
Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies)
time frame: Up to 12 months

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Patients who have received at least one dose of trabectedin - doxorubicin pegylated for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin. Exclusion Criteria: - Patients with records unavailable (lost, empty or not recoverable).

Additional Information

Official title Multicenter and Retrospective Observational Study to Analyze the Efficacy and Safety of the Combination With Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to Data Sheet
Principal investigator Laura Vidal, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Grupo Español de Investigación en Cáncer de Ovario.