Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000013369
Ethics application status
Not yet submitted
Date submitted
27/12/2007
Date registered
10/01/2008
Date last updated
10/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Immune regulation and timing of chemotherapy in advanced/recurrent ovarian cancer to evaluate tumour response
Scientific title
Immune regulation and timing of chemotherapy in advanced/recurrent ovarian cancer to evaluate tumour response
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Ovarian Cancer 2693 0
Condition category
Condition code
Cancer 2811 2811 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Synchronised chemotherapy using cyclophosphamide 100 mg orally for 3 days each 2 week cycle for at least 3 cycles
Intervention code [1] 2400 0
Treatment: Other
Intervention code [2] 2429 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3683 0
Tumour response (Recist criteria)
Timepoint [1] 3683 0
18 months
Primary outcome [2] 3697 0
CA125 response as measured in peripheral blood.Gynaecological Cancer Intergroup criteria
Timepoint [2] 3697 0
2 weeks following last of 3 treatment cycles
Secondary outcome [1] 6188 0
Survival
Timepoint [1] 6188 0
18 months
Secondary outcome [2] 6242 0
Progression free survival
Timepoint [2] 6242 0
At 6 months following trial completion

Eligibility
Key inclusion criteria
Rising CA125 (Rustin)
2 previous lines of chemotherapy
Minimum age
21 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Impending bowel obstruction

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
37
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2945 0
Self funded/Unfunded
Name [1] 2945 0
Country [1] 2945 0
Funding source category [2] 2953 0
Hospital
Name [2] 2953 0
Royal Women's Hospital
Country [2] 2953 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
132 Grattan St
Carlton
Country
Australia
Secondary sponsor category [1] 2634 0
None
Name [1] 2634 0
Address [1] 2634 0
Country [1] 2634 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4887 0
Ethics committee address [1] 4887 0
Ethics committee country [1] 4887 0
Date submitted for ethics approval [1] 4887 0
09/01/2008
Approval date [1] 4887 0
Ethics approval number [1] 4887 0

Summary
Brief summary
We have shown that the immune system regulates itself on an approximately 2 week basis.By killing the inhibitory immune cells that prevent immune attack on the tumour using low dose oral chemotherapy it is hoped that tumour cells will die and responses achieved
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28262 0
Address 28262 0
Country 28262 0
Phone 28262 0
Fax 28262 0
Email 28262 0
Contact person for public queries
Name 11419 0
Prof Michael Quinn
Address 11419 0
285 Cardigan St
Carlton
Country 11419 0
Australia
Phone 11419 0
0392215188
Fax 11419 0
Email 11419 0
[email protected]
Contact person for scientific queries
Name 2347 0
Prof Michael Quinn
Address 2347 0
285 Cardigan St
Carlton
Country 2347 0
Australia
Phone 2347 0
0392215188
Fax 2347 0
Email 2347 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.