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Prostate CancerPhase 2NCT00077402

Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer

A Phase 2 study testing fenretinide in people with Prostate Cancer, run by Cancer Therapeutics Research Group at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
fenretinide
How many people
50 participants
Where
6 sitesin 3 countries
Study dates
Nov 2003to Feb 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Singapore3 sites

  • Cancer Institute at National University Hospital

    Singapore, 119074

  • National Cancer Centre - Singapore

    Singapore, 169610

  • Johns Hopkins Singapore International Medical Centre

    Singapore, 308433

Other trials in Singapore

Australia2 sites

  • Sir Charles Gairdner Hospital - Perth

    Perth, Western Australia, 6009

  • Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

Other trials in Australia

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

About this study

Official title: A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the activity of fenretinide, in terms of the prostate-specific antigen (PSA) response rate, in patients with advanced or metastatic hormone-refractory prostate cancer.

Secondary

  • Determine the objective response rate in patients with identifiable soft tissue disease treated with this drug.
  • Determine the duration of PSA response in patients treated with this drug.
  • Determine PSA progression-free survival of patients treated with this drug.
  • Determine overall survival of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine self-rated symptoms, functions, attitudes to oral therapy, and quality of life of patients treated with this drug.

OUTLINE: This is a multicenter, open-label study.

Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course, and at the end of therapy.

PROJECTED ACCRUAL: Approximately 21-50 patients will be accrued for this study.

Conditions
Prostate Cancer
Being tested
fenretinide
Keywords
recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fenretinideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate as measured by RECIST at ≥ 9 weeks

Secondary outcomes (1)

  1. Toxicity as measured by NCI CTC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2004 (estimated)
  2. Study startNov 2003
  3. Primary completionJan 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077402
Sponsor's protocol ID
CTRG-P18/02
Other IDs
CDR0000350305, NCI-6062
Status last verified
Dec 2006
First submitted
10 Feb 2004
Last updated
15 May 2013
Results posted
No

Publications

  • Moore MM, Stockler M, Lim R, Mok TS, Millward M, Boyer MJ. A phase II study of fenretinide in patients with hormone refractory prostate cancer: a trial of the Cancer Therapeutics Research Group. Cancer Chemother Pharmacol. 2010 Oct;66(5):845-50. doi: 10.1007/s00280-009-1228-x. Epub 2010 Jan 16.

    PubMed 20082080

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fenretinide in people with Prostate Cancer, run by Cancer Therapeutics Research Group at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Singapore, Australia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate as measured by RECIST at ≥ 9 weeks. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00077402, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.

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