Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12605000375651
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
13/09/2005
Date last updated
13/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Capecitabine and oral cyclophosphamide - a novel oral treatment combination for advanced cancer
Scientific title
Phase I/II study to find the maximum tolerable dose of the combination of capecitabine and oral cyclophosphamide in the treatment of advanced cancer
Universal Trial Number (UTN)
Trial acronym
Cyclox I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 470 0
Condition category
Condition code
Cancer 548 548 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral cyclophosphamide days 1-14, plus capecitabine days 1-28 of 28 day treatment cycle.
Intervention code [1] 360 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 640 0
Dose limiting toxicities
Timepoint [1] 640 0
Assessed over the first 8 weeks of treatment
Secondary outcome [1] 1318 0
Steady state plasma levels
Timepoint [1] 1318 0
Over first 8 weeks of treatment
Secondary outcome [2] 1319 0
Develop quality of life questionnaire
Timepoint [2] 1319 0
Duration of study
Secondary outcome [3] 1320 0
Determine efficacy
Timepoint [3] 1320 0
Best tumour response assessed 8 weekly through out study
Secondary outcome [4] 1321 0
Patients are treated until disease progression, unacceptable toxicity or patient/physician decision to withdraw.
Timepoint [4] 1321 0

Eligibility
Key inclusion criteria
Histological / cytological evidence of carcinoma; performance status (WHO) 0-2; adequate bone marrow, renal and hepatic function;recovery from prior chemotherapy toxicity and calculated creatine clearance >50ml/min.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of physical integrity of upper GI tract; more than 2 prior courses of chemotherapy; prior pelvic radiation; pregnant or lactating; investigational drug within 4 weeks; history of clinically significant cardiac disease or MI in past 12 months.

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
Other
Other design features
This is a phase I study designed to determine the maximum tolerable dose, and recomended phase II dose level of the novel chemotherpy regimen
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 166 0
New Zealand
State/province [1] 166 0

Funding & Sponsors
Funding source category [1] 606 0
Commercial sector/Industry
Name [1] 606 0
Roche International & Roche Products (New Zealand) Ltd
Country [1] 606 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Findlay
Address
Country
Secondary sponsor category [1] 494 0
None
Name [1] 494 0
none
Address [1] 494 0
Country [1] 494 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36137 0
Address 36137 0
Country 36137 0
Phone 36137 0
Fax 36137 0
Email 36137 0
Contact person for public queries
Name 9549 0
Professor Michael Findlay
Address 9549 0
Cancer Trials New Zealand
Discipline of Oncology
Faculty Medical & Health Sciences
University of Auckland
Private Bag 92019
Auckland
Country 9549 0
New Zealand
Phone 9549 0
+64 9 3737599
Fax 9549 0
+64 9 3737927
Email 9549 0
mp.findlay@auckland.ac.nz
Contact person for scientific queries
Name 477 0
Professor Michael Findlay
Address 477 0
Cancer Trials New Zealand
Discipline of Oncology
Faculty Medical & Health Sciences
University of Auckland
Private Bag 92019
Auckland
Country 477 0
New Zealand
Phone 477 0
+64 9 3737599
Fax 477 0
+64 9 3737927
Email 477 0
mp.findlay@auckland.ac.nz

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.