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
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
[email protected]
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
[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.