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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00077402




Registration number
NCT00077402
Ethics application status
Date submitted
10/02/2004
Date registered
12/02/2004
Date last updated
15/05/2013

Titles & IDs
Public title
Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer
Scientific title
A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer
Secondary ID [1] 0 0
CDR0000350305
Secondary ID [2] 0 0
CTRG-P18/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - fenretinide

Treatment: Drugs: fenretinide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response rate as measured by RECIST at = 9 weeks
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Toxicity as measured by NCI CTC
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Measurable or non-measurable disease

- Metastatic disease allowed

- Castrate levels of serum testosterone (either after orchiectomy or maintained on a
luteinizing hormone-releasing hormone agonist or antagonist)

- Prostate-specific antigen (PSA) greater than 10 ng/mL at baseline and rising, with 2
consecutive increases measured at least 1 week apart*

- No known brain metastases NOTE: *If the third PSA value has not risen above the second
PSA value, a fourth measurement must be obtained that is higher than the second value

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-1

Life expectancy

- More than 12 weeks

Hematopoietic

- Absolute neutrophil count greater than 1,500/mm^3

- WBC greater than 3,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic

- AST and ALT no greater than 2.5 times upper limit of normal

- Bilirubin normal

Renal

- Creatinine normal OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Able to tolerate oral medication

- Fertile patients must use effective contraception

- No prior allergic reaction to compounds of similar chemical or biological composition
to fenretinide

- No other concurrent uncontrolled illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior cytotoxic chemotherapy

Endocrine therapy

- See Disease Characteristics

- At least 6 weeks since prior antiandrogen therapy with any of the following:

- Cyproterone

- Flutamide

- Bicalutamide

- Nilutamide

- Concurrent corticosteroids allowed provided therapy was initiated before study entry

Radiotherapy

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy, including for pain

- No concurrent radioisotopes (e.g., strontium chloride Sr 89 or samarium Sm 153
lexidronam pentasodium)

Other

- More than 4 weeks since prior investigational agents

- No concurrent antioxidants (e.g., ascorbic acid or vitamin E), vitamin A, or beta
carotene supplements

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational or commercial anticancer agents or therapies
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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 design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Perth - Perth
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Shatin, New Territories
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Cancer Therapeutics Research Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop
tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well fenretinide works in treating patients with
advanced or metastatic hormone-refractory prostate cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00077402
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Boyer
Address 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00077402