RecruitingPhase 3ACTRN12607000169448

A Phase 3 study comparing the combination of CAELYX and YONDELIS (the study drug) with CAELYX alone in subjects with advanced relapsed ovarian cancer who have previously had platinum based chemotherapy treatment (eg. Carboplatin/Cisplatin)

ET743-OVA-301 - A Phase 3, open-label multi-centre, randomized study to determine if the combination of CAELYX and YONDELIS (the study drug) improves progression free survival compared with CAELYX alone in subjects with advanced relapsed ovarian cancer in second line therapy


Sponsor

Johnson & Johnson Pharmaceutical Research & Development

Enrollment

650 participants

Start Date

Aug 23, 2005

Study Type

Interventional

Conditions

Summary

This study tests the safety and effectiveness of YONDELIS (the treatment being tested) used with CAELYX (a drug already used to treat cancer) compared to CAELYX alone. The purpose of this research study is to determine if the combination of YONDELIS and CAELYX is better at increasing the amount of time it takes for your cancer to progress compared to Caelyx alone. The study will also look at: response rate (how much your tumor shrinks in response to the drug) safety, and quality of life. In some consented patients, optional pharmacogenomic testing (DNA, RNA, and Protein testing) will occur which looks at the DNA in the tumour cells and how it responds to the study drug. The study, will examine the relationship between your response to treatment, disease progression and overall survival from your type of cancer.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for women with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back after previous treatment with platinum-based chemotherapy. It tests whether combining two drugs — CAELYX (liposomal doxorubicin, already used for ovarian cancer) and YONDELIS (trabectedin, the study drug) — works better than CAELYX alone at slowing down the cancer's progression. You may be eligible if: - You are female and 18 years of age or older - You have epithelial ovarian, fallopian tube, or primary peritoneal cancer confirmed by a tissue or cell sample - You have previously received only one platinum-based chemotherapy regimen - Your cancer came back or got worse at least 6 months after starting that treatment (or after completing 6 full treatment cycles) - Your cancer can be measured on a scan You may NOT be eligible if: - You have received more than one prior chemotherapy regimen - Your cancer got worse within 6 months of starting platinum chemotherapy - Your CA125 level is rising but there is no scan evidence of the cancer progressing Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention - Yondelis (Trabectin) Patients will be randomised to receive either Caelyx 50mg/m2 as a 90 minute intravenous infusion every 4 weeks or Caelyx 30mg/m2 as a 90 minute intravenous infu

Intervention - Yondelis (Trabectin) Patients will be randomised to receive either Caelyx 50mg/m2 as a 90 minute intravenous infusion every 4 weeks or Caelyx 30mg/m2 as a 90 minute intravenous infusion followed by Yondelis 1.1mg/m2 as a 3 hour intravenous infusion via central venous access every 3 weeks. Recruitment due to finish end June 2007. Patients will be followed until death or 2 months after the last subject has received the last dose of study drug or after 520 deaths.


Locations(1)

United States of America

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ACTRN12607000169448