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Trial registered on ANZCTR


Registration number
ACTRN12607000169448
Ethics application status
Approved
Date submitted
19/02/2007
Date registered
14/03/2007
Date last updated
14/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
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)
Scientific title
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
Secondary ID [1] 349 0
ClinicalTrials.gov: NCT00113607
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced relapsed Ovarian Cancer - to prolong progression free survival 1684 0
Condition category
Condition code
Cancer 1779 1779 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1609 0
Treatment: Drugs
Comparator / control treatment
Active control - Caelyx (Doxorubicin Hydrochloride)
Control group
Active

Outcomes
Primary outcome [1] 2486 0
Overall prolongation of progression free survival based on analysis of CT scans
Timepoint [1] 2486 0
Every 8 weeks until patient progression.
Secondary outcome [1] 4283 0
Overall survival
Timepoint [1] 4283 0
Based on 8 weekly CT scans until the patient progresses.
Secondary outcome [2] 4284 0
Demonstrate an increase in overall response rate
Timepoint [2] 4284 0
Based on 8 weekly CT scans until the patient progresses.
Secondary outcome [3] 4285 0
Compare the safety profiles of combination and monotherapy
Timepoint [3] 4285 0
Based on continuous collection and monitoring of adverse events and weekly blood draws until the patient progresses.
Secondary outcome [4] 4286 0
Quality of life and pharmacoeconomics
Timepoint [4] 4286 0
Based on a Quality of Life questionnaire completed every 6-8 weeks until the patient progresses.
Secondary outcome [5] 4287 0
Pharmacogenomics
Timepoint [5] 4287 0
Based on analysis of blood samples provided by the patient at screening (14 days before first cycle) and their first cycle (the first cycle is the first date the patient receives the first cycle of the chemotherapy clinical trial drug). This is an optional addition to the main study).

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is an open study where the patients and the treatment team are aware of the treatment. The patient is randomised using a central IVRS (Interactive Voice Response System) randomisation system (a central telephone system) used to allocate the patient to a treatment. The study nurse calls the telephone system and enters the patient's details. Patients are randomised in a 1:1 fashion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The permuted-block randomisation method will be used stratified according to platinum sensitivity (sensitive or resistant) and baseline ECOG (Eastern Cooperative Oncology Group - used to assess how a patient's disease is progressing) status (0/1 vs 2)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment outside Australia
Country [1] 487 0
United States of America
State/province [1] 487 0

Funding & Sponsors
Funding source category [1] 1929 0
Commercial sector/Industry
Name [1] 1929 0
Johnson & Johnson Pharmaceutical Research & Development
Country [1] 1929 0
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Pharmaceutical Research & Development
Address
Country
United States of America
Secondary sponsor category [1] 1741 0
Commercial sector/Industry
Name [1] 1741 0
PPD Contract organisation
Address [1] 1741 0
Country [1] 1741 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3591 0
Royal North Shore
Ethics committee address [1] 3591 0
Ethics committee country [1] 3591 0
Australia
Date submitted for ethics approval [1] 3591 0
Approval date [1] 3591 0
17/11/2005
Ethics approval number [1] 3591 0
0507143M
Ethics committee name [2] 3592 0
Burnside War Memorial
Ethics committee address [2] 3592 0
Ethics committee country [2] 3592 0
Australia
Date submitted for ethics approval [2] 3592 0
Approval date [2] 3592 0
26/10/2005
Ethics approval number [2] 3592 0
050612
Ethics committee name [3] 3593 0
Townsville Cancer Centre
Ethics committee address [3] 3593 0
Ethics committee country [3] 3593 0
Australia
Date submitted for ethics approval [3] 3593 0
Approval date [3] 3593 0
24/05/2005
Ethics approval number [3] 3593 0
42/05
Ethics committee name [4] 3594 0
Monash Medical Centre
Ethics committee address [4] 3594 0
Ethics committee country [4] 3594 0
Australia
Date submitted for ethics approval [4] 3594 0
Approval date [4] 3594 0
10/02/2006
Ethics approval number [4] 3594 0
05084A
Ethics committee name [5] 3595 0
Royal Adelaide Hospital
Ethics committee address [5] 3595 0
Ethics committee country [5] 3595 0
Australia
Date submitted for ethics approval [5] 3595 0
Approval date [5] 3595 0
26/10/2005
Ethics approval number [5] 3595 0
050612

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27543 0
Address 27543 0
Country 27543 0
Phone 27543 0
Fax 27543 0
Email 27543 0
Contact person for public queries
Name 10798 0
Dr Gary Renshaw
Address 10798 0
Johnson & Johnson PRD, LLC
920 U.S. Route 202 South
P.O. Box 300
Raritan, NJ 08869-0602
Country 10798 0
United States of America
Phone 10798 0
+1 908 9274649
Fax 10798 0
+1 908 5750626
Email 10798 0
[email protected]
Contact person for scientific queries
Name 1726 0
Dr Gary Renshaw
Address 1726 0
Johnson & Johnson PRD LLC
920 U.S. Route 202 South
P.O. Box 300
Raritan NJ 08869-0602
Country 1726 0
United States of America
Phone 1726 0
+1 908 9274649
Fax 1726 0
+1 908 5750626
Email 1726 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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