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Prostate CancerPhase 2NCT00054015

3-AP in Treating Patients With Advanced Prostate Cancer

A Phase 2 study testing triapine in people with Prostate Cancer, run by Vion Pharmaceuticals at 2 sites in United States.

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 use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy. 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?
triapine
How many people
Not given
Where
2 sitesUnited States
Study dates
Dec 2002to Jan 2008
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:

  • Diagnosis of hormone-refractory metastatic prostate cancer by one of the following methods:
  • Measurable disease
  • PSA level of at least 5 ng/mL with a positive bone scan
  • Objective evidence of progressive metastatic disease in the past 3 months defined by any of the following:
  • An increase in PSA value of at least 25% (minimum absolute increase of 5 ng/mL) on at least 2 successive occasions, at least 2 weeks apart
  • A new symptomatic lesion on bone scan
  • A new metastases not in bone
  • Growth of existing non-bone measurable metastatic disease NOTE: An increase in pain or symptoms alone without other evidence of progression, or elevation of PSA or serum alkaline phosphatase alone without evidence of metastatic disease is not sufficient
  • Prior bilateral orchiectomy or other primary hormonal treatment with evidence of treatment failure
  • Patients with no prior bilateral orchiectomy must have a testosterone level less than 50 ng/mL and must continue leuteinizing hormone-releasing hormone therapy while on study
  • No known active CNS metastases (excluding prior CNS metastases with currently stable disease after treatment )

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • ALT/AST no greater than 5 times upper limit of normal
  • Albumin greater than 2.5 g/dL
  • Chronic hepatitis allowed

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • No myocardial infarction within the past 3 months
  • No unstable angina
  • No uncontrolled arrhythmias
  • No uncontrolled congestive heart failure

Pulmonary

  • No dyspnea at rest

Other

  • Nutrition adequate (caloric intake considered adequate for maintenance of weight)
  • Fertile patients must use effective contraception
  • No prior or concurrent malignancies except for non-metastatic basal cell or squamous cell skin cancer or any stage I malignancy curatively resected more than 5 years ago
  • No active uncontrolled infectious process
  • No other life-threatening illness
  • No peripheral neuropathy greater than grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 2 weeks since prior biologic therapy

Chemotherapy

  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since other prior hormonal therapy including any of the following:
  • Megestrol
  • Finasteride
  • Herbal products known to decrease PSA levels (e.g., saw palmetto and PC-SPES)
  • Systemic corticosteroids
  • At least 4 weeks since prior flutamide therapy (6 weeks for bicalutamide or nilutamide) with continued evidence of progressive disease documented by at least 1 PSA value after discontinuation

Radiotherapy

  • At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)
  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered

Other

  • No other concurrent investigational agents
  • No other concurrent anticancer treatment

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

Other trials in United States

About this study

Official title: A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy.

Read the detailed description

OBJECTIVES:

  • Determine the response rate in patients with advanced hormone-refractory prostate cancer treated with 3-AP.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-AP IV over 2 hours on days 1-4. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2-3 months for up to 1 year.

PROJECTED ACCRUAL: Approximately 13-27 patients will be accrued for this study.

Conditions
Prostate Cancer
Being tested
triapine
Keywords
recurrent prostate cancer, stage IV prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • triapineDrug

Timeline

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

  1. First posted6 Feb 2003 (estimated)
  2. Study startDec 2002
  3. Study completionJan 2008

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054015
Sponsor's protocol ID
CDR0000269675
Other IDs
VION-CLI-024, MCC-13110, MCC-IRB-100798
Status last verified
Apr 2004
First submitted
5 Feb 2003
Last updated
6 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing triapine in people with Prostate Cancer, run by Vion Pharmaceuticals at 2 sites in United States.

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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

Where can I read the original study information?
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 6 Nov 2013.

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