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Trial registered on ANZCTR


Registration number
ACTRN12609000436279
Ethics application status
Approved
Date submitted
25/05/2009
Date registered
11/06/2009
Date last updated
11/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised phase II study comparing the activity and toxicity profiles of Carboplatin plus pegylated Liposomal Doxorubicin (CLD) versus Carboplatin plus Paclitaxel (CP) in potentially platinum sensitive ovarian cancer patients
Scientific title
A randomised phase II study comparing the clinical response and toxicity of Carboplatin plus pegylated Liposomal Doxorubicin (CLD) vs Carboplatin plus Paclitaxel (CP) in potentially platinum sensitive ovarian cancer patients
Secondary ID [1] 891 0
HE4B99 {issuing authority: Hellenic Cooperative Oncology Group (HeCOG)}
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
platinum sensitive ovarian cancer 4849 0
Condition category
Condition code
Cancer 237196 237196 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
chemotherapy with Carboplatin plus pegylated Liposomal Doxorubicin (CLD): pegylated Liposomal Doxorubicin was administered as an intravenous infusion of 90 min at a dose of 45 mg/m2 followed by an intravenous infusion of 1 hour of Carboplatin at Area Under the Curve (AUC) 5, on day 1. Cycles were repeated every 28 days. Premedication included 20 mg dexamethasone, 4mg dyphenidramine, 150 mg ranitidine administered intravenously immediatelly prior to pegylated Liposomal Doxorubicin administration. The dose of carboplatin based on AUC was calculated by the estimated creatinine clearance using Calvert’s formula. Six cycles of chemotherapy were administered unless evidence of disease progression or unacceptable toxicity occurred.
Intervention code [1] 236631 0
Treatment: Drugs
Comparator / control treatment
chemotherapy with Carboplatin plus Paclitaxel (CP):Paclitaxel was administered at 175 mg/m2 as a 3hr intravenous infusion followed by an 1hour intravenous infusion of Carboplatin at an AUC5, on day 1. Cycles were repeated every 21 days. All patients received standard premedication of dexamethasone, dyphenhydramine and ranitidine prior to paclitaxel (20 mg dexamethasone, 4mg dyphenidramine, 150 mg ranitidine were administered orally 12 hours prior to paclitaxel and the same doses intravenously again immediatelly prior to paclitaxel administration). Patients in the intervention group received the above premedication only immediately prior to liposomal doxorubicin intravenously . The dose of carboplatin based on AUC was calculated by the estimated creatinine clearance using Calvert’s formula. Six cycles of chemotherapy were administered unless evidence of disease progression or unacceptable toxicity occurred.
Control group
Active

Outcomes
Primary outcome [1] 238008 0
response was assessed clinically, and by imaging of measurable disease sites, ie by Computerised Tomography (CT) scans of chest, abdomen/pelvis as indicated and tumour marker measurements. Standard World Health Organisation (WHO) criteria were applied for assessment of response, as these were commonly used prior to the broad introduction of Response Criteria In Solid Tumours (RECIST) criteria, by our group and others, and at the time when this study was initiated. For patients without measurable disease, response was determined based on repetitive Cancer Antigen-125 (CA125) measurements using the algorithm proposed by Rustin and according to CA-125 Rustin's criteria.
Timepoint [1] 238008 0
response was assessed at the completion of every second cycle, i.e at the beggining of cycle 3, at the beggining of cycle 5 and then after completion of cycle 6.
Secondary outcome [1] 242147 0
Toxicity criteria were those adopted by the World Health Organization.
Timepoint [1] 242147 0
toxicity was assessed on day 1 of each cycle, detailing toxicity-related events of each previously completed cycle

Eligibility
Key inclusion criteria
Women at least 18 years old, with histologically confirmed recurrent ovarian cancer (OC), 6 months or more after platinum-based chemotherapy, patients with bidimensionally measurable disease or only elevated serum tumour marker CA125 (more than twice the upper limit of normal), with Eastern Cooperative Oncology Group (ECOG) performance status 0–2 and life expectancy of at least 3 months were eligible. Adequate bone marrow, hepatic and renal functions were required.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of malignancy other than completely excised in situ carcinoma of the cervix or basal carcinoma of the skin, prior or recurrent central nervous system metastases, serious cardiac disease, other serious medical illness or inability to comply with the treatment plan and follow-up visits were excluded. Also patients with residual neurotoxicity from previous platinum and/or taxane chemotherapy were excluded.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1804 0
Greece
State/province [1] 1804 0

Funding & Sponsors
Funding source category [1] 5011 0
Other Collaborative groups
Name [1] 5011 0
Hellenic Cooperative Oncology Group
Address [1] 5011 0
Hatzikonstanti street No 18, Athens 11524
Country [1] 5011 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
Hatzikonstanti street No 18, Athens 11524
Country
Greece
Secondary sponsor category [1] 4531 0
None
Name [1] 4531 0
Address [1] 4531 0
Country [1] 4531 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Platinum-based combinations are standard 2nd-line treatment for platinum-sensitive ovarian cancer. This randomized phase II study was conducted to evaluate the efficacy and safety of a carboplatin-based combination with pegylated LD versus the standard combination of carboplatin with paclitaxel in patients with ovarian cancer relapsing at least 6 months after 1st-line platinum-based therapy. It is hypothesised that the combination of carboplatin-pegylated LD will be at least as effective with a more favourable toxicity profile than the standard combination with paclitaxel.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29642 0
Address 29642 0
Country 29642 0
Phone 29642 0
Fax 29642 0
Email 29642 0
Contact person for public queries
Name 12889 0
D. Bafaloukos
Address 12889 0
Hatzikonstanti street No 18, Athens 11524
Country 12889 0
Greece
Phone 12889 0
+30 210-4296620
Fax 12889 0
Email 12889 0
dbafaloukos@metropolitan-hospital.gr
Contact person for scientific queries
Name 3817 0
H. Linardou
Address 3817 0
Hatzikonstanti street No 18, Athens 11524
Country 3817 0
Greece
Phone 3817 0
+30 210-4809852
Fax 3817 0
Email 3817 0
elinardou@metropolitan-hospital.gr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary