Prostate CancerPhase 2NCT00245895

Study of Aranesp to Treat Anemia in Prostate Cancer Patients.

A Phase 2 study testing Aranesp in people with Prostate Cancer and Anemia, run by University of Washington 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

The purpose of this study is to see if darbepoetin alfa is an effective treatment for anemia in prostate cancer patients and, if so, what dose is most effective. Sometimes prostate cancer patients have low red blood cell counts (low hemoglobin) from various treatments they are receiving, such as chemotherapy. Read more about this study

Who is it for?: Any age, men only
Conditions the study is for: Prostate Cancer, Anemia
What is being tested?: Aranesp
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 2 sitesUnited States
Study dates: Apr 2003to Feb 2005
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 Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients must have either histologically confirmed adenocarcinoma of the prostate or clinical evidence including a PSA greater than 50, with evidence of bone metastases, currently receiving either androgen suppression or chemotherapy.
Patients on concurrent androgen deprivation treatment that consists of either orchiectomy or a GnRH agonist (Zoladex or Lupron) with or without and androgen receptor antagonist (Casodex, Nilandron, or Eulexin) therapy, as long as therapy was initiated within the last 3 months. Finasteride treatment must be discontinued. Secondary hormonal therapy with DES or ketoconazole is permitted.
Patients may have a history of radiation therapy, providing that at least 6 weeks have elapsed from the last treatment date to study day 1.
Patients must have a life expectancy of at least 12 months and a zubrod performance status of 0-2.
Patients must not have evidence of hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery.
Patients must have serum creatinine level of less than or equal to 2 mg/dL.
Patients must have adequate liver function, as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2 x ULN within the 3 months prior to screening.
Before any study-specific procedure, the patients must give written informed consent to participate in the study.

Who cannot join

Patients presenting an active primary or metastatic malignancy involving the CNS. Patients with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study, if they have had no clinical signs or symptoms of, not treatment for CNS disease, and no history of seizures within the previous 2 years.
Patients receiving rHuEPO therapy within 4 weeks prior to first dose of the study drug.
Active bleeding or RBC transfusion within 4 weeks prior to fist dose of study drug.
Patients with an active seizure disorder. Patients with a previous history of seizure disorder will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of anti-convulsant medication for the previous 5 years.
Patients with uncontrolled angina, congestive heart failure or uncontrolled cardiac arrhythmia.
Patients with uncontrolled hypertension

Show all 14Show fewer

Patients with a history of hyperviscosity syndrome
Patients with evidence of clinically significant systemic active infection or inflammatory disease
Patients with known positive test for human immunodeficiency virus (HIV) infection
Patients with inadequate iron stores (Fe/TIBC less than 15% and ferritin less than 10.0 mg/L)
Patients with a history or any primary hematologic disorder that could cause anemia
Patients currently receiving, or not yet 30 days past receiving (prior to the first dose of study drug), other investigational agents or devices not approved in any indication by the governing regulatory authority. Note: an exception will be made for patients receiving DN-101, a new formulation of calcitriol, on an investigational study.
Patients who have previously received Aranesp (darbepoetin alfa) within 4 weeks prior to fist dose of study drug.
Patients with a known hypersensitivity to the active substance or any of the excipients.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Oregon Health and Sciences University
Portland, Oregon, 97239
Seattle Cancer Care Alliance
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase II Study of Aranesp (Darbepoetin Alfa) to Treat Anemia in Prostate Cancer Patients.

Read the detailed description

This study is to evaluate the effectiveness of Darbepoetin alfa, (also referred to as Aranesp or NESP), to assess what dose of NESP is required to treat anemia in prostate cancer patients, what the side effects of NESP are, and whether NESP will affect the patients' quality of life. NESP is approved by the FDA for the treatment of anemia in patients with chronic kidney failure and for the treatment of anemia in cancer patients who are receiving chemotherapy. It is considered experimental for the treatment of anemia in prostate cancer patients.

Conditions: Prostate Cancer, Anemia
Being tested: Aranesp
Keywords: Anemia,, Prostate Cancer
Medical subject headings: Prostatic Neoplasms, Anemia

What participants receive

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

AranespDrug
Also called darbepoetin
Aranesp

Study groups in NCT00245895
Study group	Role	What they receive
1	Active comparator	Aranesp Receives: Drug: Aranesp

What is being measured

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

Hemoglobin greater than or equal to 12.5
Measured: Feb 2005

Secondary outcomes (4)

The median time to achieving the primary endpoint.
Measured: Feb 2005
The dose required to achieve the primary endpoint of more than 50% of patients.
Measured: Feb 2005
A description of the qualitative and quantitative toxicities of the administration of Aranesp (darbepoetin alfa) in this patient population.
Measured: Feb 2005
Changes in QOL from baseline compared to 3 and 6 month time point using the anemia subscale of FACT-P.
Measured: Feb 2005

Timeline

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

Apr 2003Feb 2005

First posted28 Oct 2005 (estimated)
Study startApr 2003
Study completionFeb 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00245895
Sponsor's protocol ID: 03-6503-A
Status last verified: Nov 2007
First submitted: 26 Oct 2005
Last updated: 29 Nov 2007
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Aranesp (Darbepoetin Alfa) to Treat Anemia in Prostate Cancer Patients.
ClinicalTrials.gov ID: NCT00245895
Acronym / sponsor ID: 03-6503-A
Conditions: Prostate Cancer, Anemia
Keywords: Anemia,, Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Amgen
Study start: Apr 2003
Study completion: Feb 2005 (actual)
First posted: 28 Oct 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Active comparator	Drug: AranespAranesp

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Patients must have either histologically confirmed adenocarcinoma of the prostate or clinical evidence including a PSA greater than 50, with evidence of bone metastases, currently receiving either androgen suppression or chemotherapy.
Patients on concurrent androgen deprivation treatment that consists of either orchiectomy or a GnRH agonist (Zoladex or Lupron) with or without and androgen receptor antagonist (Casodex, Nilandron, or Eulexin) therapy, as long as therapy was initiated within the last 3 months. Finasteride treatment must be discontinued. Secondary hormonal therapy with DES or ketoconazole is permitted.
Patients may have a history of radiation therapy, providing that at least 6 weeks have elapsed from the last treatment date to study day 1.
Patients must have a life expectancy of at least 12 months and a zubrod performance status of 0-2.
Patients must not have evidence of hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery.

Key exclusion criteria (14 listed)

Patients presenting an active primary or metastatic malignancy involving the CNS. Patients with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study, if they have had no clinical signs or symptoms of, not treatment for CNS disease, and no history of seizures within the previous 2 years.
Patients receiving rHuEPO therapy within 4 weeks prior to first dose of the study drug.
Active bleeding or RBC transfusion within 4 weeks prior to fist dose of study drug.
Patients with an active seizure disorder. Patients with a previous history of seizure disorder will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of anti-convulsant medication for the previous 5 years.
Patients with uncontrolled angina, congestive heart failure or uncontrolled cardiac arrhythmia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AranespAlso: darbepoetinAranesp	Drug	1

Primary outcome

Hemoglobin greater than or equal to 12.5
Time frame: Feb 2005

4 secondary outcomes

The median time to achieving the primary endpoint.
Time frame: Feb 2005
The dose required to achieve the primary endpoint of more than 50% of patients.
Time frame: Feb 2005
A description of the qualitative and quantitative toxicities of the administration of Aranesp (darbepoetin alfa) in this patient population.
Time frame: Feb 2005
Changes in QOL from baseline compared to 3 and 6 month time point using the anemia subscale of FACT-P.
Time frame: Feb 2005

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2007.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Celestia S Higano, MD principal investigator

University of Washington

Tomasz M Beer, MD principal investigator

Oregon Health and Science University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aranesp in people with Prostate Cancer and Anemia, run by University of Washington 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?

The sponsor lists 8 inclusion and 14 exclusion criteria. 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 29 Nov 2007. 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.

What does the primary outcome measure?

Hemoglobin greater than or equal to 12.5 (time frame: Feb 2005). 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 NCT00245895.

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 29 Nov 2007.