AzTrials
AzTrials

Hormone Refractory Prostate CancerPhase 2NCT00313482

PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC

A Phase 2 study testing Sargramostim, Docetaxel and Prednisone in people with Hormone Refractory Prostate Cancer, run by Veeda Oncology at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a Phase II, open-label study in male patients with metastatic HRPC. Each cycle will be 21 days (3 weeks). Patients will receive the following drugs: Docetaxel 75 mg/m2 IV given over 1 hour on Day 1. Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease progression. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Hormone Refractory Prostate Cancer
What is being tested?
Sargramostim, Docetaxel and Prednisone
How many people
35 participants
Where
1 siteUnited States
Study dates
Apr 2006to Aug 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 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have signed an IRB-approved informed consent.
  • Patients must be male with histologically confirmed metastatic adenocarcinoma of the prostate with progressive disease, despite androgen deprivation.
  • Patients must have a history of prior hormone therapy (must fulfill one of the following criteria):
  • Castration and/or luteinizing-hormone releasing hormone (LHRH) agonist
  • Antiandrogen therapy (flutamide, nilutamide, bicalutamide, or cyproterone acetate)
  • Antiandrogen therapy withdrawal
Show all 27Show fewer
  • Estramustine monotherapy
  • Other hormonal therapy (eg, ketoconazole). Note: Patients must be off ketoconazole at least 1 month. If PSA is decreasing, the patient must demonstrate a rising PSA on at least 2 sequential reading at least 2 weeks apart.
  • Patients must have a serum testosterone <50 ng/dL (if the patient has not undergone orchiectomy, he must continue primary androgen deprivation with LHRH analogue).
  • Patient must fulfill one of the following criteria:
  • Patients with measurable disease:
  • Patients must have disease progression defined by the RECIST criteria.
  • Patients with no measurable disease:
  • Patients with PSA only disease must have an elevated PSA by Consensus Criteria. -OR-
  • Patients with a positive bone scan must also have elevated PSA defined by Consensus Criteria.
  • Progressive disease (as defined above) must be documented after discontinuation of hormonal therapy.
  • Patients who are receiving an antiandrogen as part of primary androgen ablation must also demonstrate disease progression following discontinuation of the antiandrogen.
  • Patients on antiandrogen therapy must discontinue therapy and subsequently demonstrate disease progression (at least 4 weeks since prior flutamide or nilutamide, 8 weeks since prior bicalutamide).
  • Patients must have discontinued all agents or herbal products known to decrease PSA levels (eg, Megace [megestrol acetate], Saw Palmetto, and PC-SPEC) or any systemic corticosteroid at least 4 weeks prior to enrollment.
  • Patients must have Karnofsky Performance Status (PS) >60.
  • Patients must have a life expectancy >3 months.
  • Patients must be >18 years of age.
  • Patients may have received prior radiation (except for radiation to the entire pelvis), provided that less than 25% of the bone marrow has been treated, and the patient has recovered from the acute toxic effects of treatment prior to trial enrollment. Irradiation of a symptomatic lesion, or one that may produce disability (eg, unstable femur) prior to study initiation is permitted, provided other measurable disease is present. Prior radiation treatment must have been completed at least 4 weeks prior to enrollment. Lesions that have been irradiated in the advanced disease setting may not be included as sites of measurable disease.
  • Patients must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
  • Patients must have absolute neutrophil count (ANC) >1500/μL, platelet count >100,000/μL, and hemoglobin >8 mg/dL.
  • Patients must have alanine transaminase (ALT), aspartate transaminase (AST), and total bilirubin within normal limits (WNL), serum creatinine <1.5 x upper limit of normal (ULN).
  • Patients must be willing and able to self-administer or have a caregiver who can administer in compliance with the protocol (sargramostim).

Who cannot join

  • Prior systemic chemotherapy for the treatment of HRPC, with the exception of estramustine monotherapy.
  • Prior treatment with ketoconazole, aminoglutethimide, or corticosteroids for the treatment of progressive prostate cancer.
  • No prior immunotherapy with the exception of routine immunizations.
  • Myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (New York Heart Association Class III or higher, see Appendix II) or uncontrolled cardiac arrhythmia.
  • Patients with known HIV-positive status.
  • Major surgery or radiation therapy <4 weeks prior to enrollment.
Show all 16Show fewer
  • Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
  • Patients with a history of severe hypersensitivity reaction to docetaxel, prednisone, sargramostim, yeast-derived products, other drugs formulated with polysorbate 80, or any of the components in these drugs.
  • Patients with poorly controlled diabetes (fasting blood glucose >250 mg/dL) despite optimization of medical therapy.
  • Patients with serious uncontrolled intercurrent infections, nonmalignant medical illnesses, or active uncontrolled autoimmune disease. Note: suppressive antibiotic therapy for chronic urinary tract infections is allowed.
  • Patients with a systemic fungal infection.
  • Patients with psychiatric illness/social situations that would limit compliance with treatment or adequate informed consent.
  • Any patient who is unable to comply with requirements of study.
  • Patients with symptomatic peripheral neuropathy Grade >2 (NCI Common Toxicity Criteria Version 3.0.
  • Patients with known brain or leptomeningeal involvement.
  • Patients with second primary malignancy, except adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated >5 years previously and with no other evidence of recurrence.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Veeda Oncology

    Columbus, Ohio, 43215

Other trials in United States

About this study

Official title: A Phase II Trial of Docetaxel/Prednisone in Combination With Sargramostim as Treatment for Hormone-refractory Prostate Cancer

This is a Phase II, open-label study in male patients with metastatic HRPC.

Each cycle will be 21 days (3 weeks). Patients will receive the following drugs:

Read more
  • Docetaxel 75 mg/m2 IV given over 1 hour on Day 1.
  • Prednisone 5 mg orally twice daily beginning on Day 1 and continuing until disease progression.
  • Sargramostim 250 mcg/m2 SC on Days 2-15 of each cycle. Patients will be evaluated every 4 cycles (12 weeks) for response using RECIST criteria. PSA response will be evaluated according to the National Cancer Institute (NCI) PSA Working Group Criteria. To evaluate the safety of this drug combination, patients will be evaluated at each clinic visit for adverse events. Toxicities will be assessed per National Cancer Institute (NCI) CTCAE Version 3.0.

Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study.

Patients will receive a maximum of 10 cycles of treatment.

What participants receive

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

  • SargramostimDrug

    Also called Leukine

    250 mcg/m2 SC days 2-15 of each cycle

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 IV over 1 hour on Day 1 of each cycle

  • PrednisoneDrug

    5 mg orally BID on Day 1 continuously

What is being measured

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

  1. To evaluate the effects of the combination of docetaxel/prednisone with sargramostim on progression-free survival in chemotherapy-naïve male patients with hormone-refractory prostate cancer (HRPC).

    Measured: unk

Secondary outcomes (3)

  1. To evaluate the response (as demonstrated by PSA and/or measurable disease) to the combination of docetaxel/prednisone with sargramostim.

    Measured: unk

  2. To evaluate the 1-year and 2-year survival following treatment with the combination of docetaxel/prednisone with sargramostim.

    Measured: unk

  3. To evaluate the safety of the combination of docetaxel/prednisone with sargramostim.

    Measured: unk

Timeline

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

  1. First posted12 Apr 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionAug 2008
  4. Study completionAug 2008

Why it stopped: Low accrual

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00313482
Sponsor's protocol ID
I-05-011
Status last verified
May 2012
First submitted
10 Apr 2006
Last updated
11 May 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sargramostim, Docetaxel and Prednisone in people with Hormone Refractory Prostate Cancer, run by Veeda Oncology at 1 site 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 27 inclusion and 16 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: stopped early, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: Low accrual). Results are not available in the source record.

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?

To evaluate the effects of the combination of docetaxel/prednisone with sargramostim on progression-free survival in chemotherapy-naïve male patients with hormone-refractory prostate cancer (HRPC). (time frame: unk). 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 NCT00313482.

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 11 May 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in