Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000390684
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase II trial of weekly docetaxel (Taxotere) for patients with relapsed ovarian cancer who have previously received paclitaxel
Scientific title
A phase II trial of weekly docetaxel (Taxotere) for patients with relapsed ovarian cancer who have previously received paclitaxel
Secondary ID [1] 159 0
Australia and New Zealand Gynecological Oncology Group: ANZGOG 02-01
Secondary ID [2] 160 0
National Clinical Trials Registry: NCTR575
Universal Trial Number (UTN)
Trial acronym
ANZGOG 02-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed ovarian cancer 494 0
Condition category
Condition code
Cancer 574 574 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 cycles of docetaxel where a cycle is once a week for 5 weeks followed by a rest week.
Intervention code [1] 428 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 659 0
Tumour response
Timepoint [1] 659 0
Assessed every 6 weeks
Secondary outcome [1] 1365 0
Overall survival
Timepoint [1] 1365 0
Secondary outcome [2] 1366 0
Time to progression
Timepoint [2] 1366 0
Secondary outcome [3] 1367 0
Toxicity
Timepoint [3] 1367 0

Eligibility
Key inclusion criteria
* Histologically proven epithelial carcinoma of the ovary, primary peritoneal carcinoma or fallopian tube carcinoma. * Patients must have previously received paclitaxel, and relapsed or progressed after cessation of paclitaxel. * Patients must have been treated previously with at least one platinum-containing chemotherapy regimen (platinum refers to either carboplatin or cisplatin). * Patients must have disease that is unidimensionally measurable or be suitable for assessment of CA125 response. Patients without measurable disease who are to be followed by CA125 must have a CA125 > 70 U/ml. * Patients may or may not have received hormonal therapy, immunotherapy or localized radiation therapy (previous radiotherapy exposure should not compromise the evaluation of the measurable/evaluable disease sites). Patients must have been off all previous non-cytotoxic therapy for at least four weeks before study entry and must have recovered from the effects of prior therapy. For patients on hormonal therapy who have clear evidence of progression on this treatment, a 2-week interval will be acceptable. Prior radiotherapy should have involved < 25% of bone marrow. * No prior chemotherapy/investigational drug therapy in the 4 weeks preceding study entry. In case of previous treatment with mitomycin-C, high-dose carboplatin (dose > 600mg/m2 or > AUC 7) or nitrosoureas, a 6-week interval will be required. * WHO performance status 0-2. * Non-pregnant, non-lactating female patients. Patients of childbearing potential must implement adequate contraceptive measures during study participation. * Age > 18 years. * Life expectancy greater than or equal to 12 weeks. * Adequate haematological, renal and hepatic functions as defined by: (i) Haematology: - Neutrophils > 1.5 x 109/l- Platelets > 100 x 109/l. (ii) Hepatic function:- Total bilirubin < upper-normal limit (UNL). - AST and ALT < 2.5 x UNL. - ALP < 5 x UNL (unless patient has bone metastases without any malignant or non-malignant liver disease). - Patients with AST and /or ALT > 1.5 x UNL associated with ALP > 2.5 x UNL are not eligible for the study. (iii) Renal function: - Creatinine < 1.5 x UNL. * Patient's written informed consent must be obtained before any study specific screening procedures are performed, and in accordance to the local Ethics Committee requirements. * Patients must be accessible for treatment and follow-up.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/10/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 624 0
Commercial sector/Industry
Name [1] 624 0
Aventis
Country [1] 624 0
Primary sponsor type
Government body
Name
NHMRC Clinical Trial Centre c/- Univ of Sydney
Address
Country
Australia
Secondary sponsor category [1] 509 0
None
Name [1] 509 0
N/A
Address [1] 509 0
Country [1] 509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1745 0
Border Medical Oncology
Ethics committee address [1] 1745 0
Ethics committee country [1] 1745 0
Australia
Date submitted for ethics approval [1] 1745 0
Approval date [1] 1745 0
Ethics approval number [1] 1745 0
Ethics committee name [2] 1746 0
Burnside Hospital
Ethics committee address [2] 1746 0
Ethics committee country [2] 1746 0
Australia
Date submitted for ethics approval [2] 1746 0
Approval date [2] 1746 0
Ethics approval number [2] 1746 0
Ethics committee name [3] 1747 0
Cabrini Hospital
Ethics committee address [3] 1747 0
Ethics committee country [3] 1747 0
Australia
Date submitted for ethics approval [3] 1747 0
Approval date [3] 1747 0
Ethics approval number [3] 1747 0
Ethics committee name [4] 1748 0
Canberra Hospital
Ethics committee address [4] 1748 0
Ethics committee country [4] 1748 0
Australia
Date submitted for ethics approval [4] 1748 0
Approval date [4] 1748 0
Ethics approval number [4] 1748 0
Ethics committee name [5] 1749 0
Christchurch Hospital
Ethics committee address [5] 1749 0
Ethics committee country [5] 1749 0
New Zealand
Date submitted for ethics approval [5] 1749 0
Approval date [5] 1749 0
Ethics approval number [5] 1749 0
Ethics committee name [6] 1750 0
Geelong Hospital
Ethics committee address [6] 1750 0
Ethics committee country [6] 1750 0
Australia
Date submitted for ethics approval [6] 1750 0
Approval date [6] 1750 0
Ethics approval number [6] 1750 0
Ethics committee name [7] 1751 0
Liverpool Hospital
Ethics committee address [7] 1751 0
Ethics committee country [7] 1751 0
Australia
Date submitted for ethics approval [7] 1751 0
Approval date [7] 1751 0
Ethics approval number [7] 1751 0
Ethics committee name [8] 1752 0
Mercy Hospital for Women
Ethics committee address [8] 1752 0
Ethics committee country [8] 1752 0
Australia
Date submitted for ethics approval [8] 1752 0
Approval date [8] 1752 0
Ethics approval number [8] 1752 0
Ethics committee name [9] 1753 0
Newcastle Mater Miersicordiae Hospital
Ethics committee address [9] 1753 0
Ethics committee country [9] 1753 0
Australia
Date submitted for ethics approval [9] 1753 0
Approval date [9] 1753 0
Ethics approval number [9] 1753 0
Ethics committee name [10] 1754 0
Prince of Wales Hospital
Ethics committee address [10] 1754 0
Ethics committee country [10] 1754 0
Australia
Date submitted for ethics approval [10] 1754 0
Approval date [10] 1754 0
Ethics approval number [10] 1754 0
Ethics committee name [11] 1755 0
Royal Adelaide Hospital
Ethics committee address [11] 1755 0
Ethics committee country [11] 1755 0
Australia
Date submitted for ethics approval [11] 1755 0
Approval date [11] 1755 0
Ethics approval number [11] 1755 0
Ethics committee name [12] 1756 0
Royal Brisbane Hospital
Ethics committee address [12] 1756 0
Ethics committee country [12] 1756 0
Australia
Date submitted for ethics approval [12] 1756 0
Approval date [12] 1756 0
Ethics approval number [12] 1756 0
Ethics committee name [13] 1757 0
Royal Prince Alfred Hospital
Ethics committee address [13] 1757 0
Ethics committee country [13] 1757 0
Australia
Date submitted for ethics approval [13] 1757 0
Approval date [13] 1757 0
Ethics approval number [13] 1757 0
Ethics committee name [14] 1758 0
Royal Women's Hospital, Melbourne
Ethics committee address [14] 1758 0
Ethics committee country [14] 1758 0
Australia
Date submitted for ethics approval [14] 1758 0
Approval date [14] 1758 0
Ethics approval number [14] 1758 0
Ethics committee name [15] 1759 0
Sir Charles Gairdner Hospital
Ethics committee address [15] 1759 0
Ethics committee country [15] 1759 0
Australia
Date submitted for ethics approval [15] 1759 0
Approval date [15] 1759 0
Ethics approval number [15] 1759 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36282 0
Address 36282 0
Country 36282 0
Phone 36282 0
Fax 36282 0
Email 36282 0
Contact person for public queries
Name 9617 0
Kathleen Scott
Address 9617 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9617 0
Australia
Phone 9617 0
+61 2 95625069
Fax 9617 0
+61 2 95625094
Email 9617 0
[email protected]
Contact person for scientific queries
Name 545 0
Dr Danny Rischin
Address 545 0
Department of Gynaecological Oncology
Mercy Hospital for Women
7th Floor
126 Clarendon St
East Melbourne VIC 3002
Country 545 0
Australia
Phone 545 0
+61 3 96561804
Fax 545 0
+61 3 96561408
Email 545 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.