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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000169448

Enrollment

650

Registered

2007-03-14

Start date

2005-08-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer or primary peritoneal cancerPrior treatment with only 1 platinum based chemotherapy regimenRecurrence or progression after 6 full cycles of a complete 6 cycle initial treatment or 6 months after the beginning (first dose) of the initial treatmentMeasurable disease according to RECIST guidelines (Response Evaluation Criteria In Solid Tumours - guidelines used to analyse tumours).

Exclusion criteria

More than one prior chemotherapy regimenDisease progression within 6 months of first dose of platinum based chemotherapyIsolated rise in CA125 without radiologically documented evidence of disease progression.

Outcome results