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AzTrials

PainPhase 2NCT00005960

Combination Chemotherapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase 2 study testing filgrastim, cyclophosphamide and docetaxel in people with Pain and Prostate Cancer, run by Amgen at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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. Giving more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have prostate cancer that has not… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Pain, Prostate Cancer
What is being tested?
filgrastim, cyclophosphamide and docetaxel
Type of treatment
Surgery or procedure
How many people
Not given
Where
6 sitesUnited States
Study dates
Oct 1999to not given
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 proven adenocarcinoma of the prostate that is chemotherapy naive and refractory to hormonal therapy with combined androgen blockade No concurrent antiandrogen therapy withdrawal: Must continue antiandrogen therapy until completion of study OR Must discontinue flutamide at least 4 weeks before or bicalutamide at least 8 weeks before study enrollment, and must have disease progression off antiandrogen therapy, defined by serial increase in PSA (at least 2 measurements taken at least 2 weeks apart) or measurable tumor Concurrent LHRH antagonist allowed if no prior orchiectomy No minimum PSA level required Measurable or evaluable disease An increase in PSA or pain without measurable or evaluable disease does not constitute hormone refractory disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF normal No impaired cardiac status (e.g., history of severe heart disease, cardiomyopathy, or congestive heart failure) Other: No active infection, defined by the following: Clinical syndrome consistent with a viral or bacterial infection (e.g., influenza, upper respiratory infection, or urinary tract infection) Fever with a clinical site of infection identified Microbiologically documented infection including, but not limited to, bacteremia or septicemia HIV negative No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer No psychiatric, addictive, or other disorder that would preclude informed consent or compliance No hypersensitivity to E. coli derived proteins or drugs formulated with polysorbate 80 (e.g., human insulin)

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent WBC transfusions No other concurrent biologic therapy Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agent No concurrent acetaminophen for fever prophylaxis

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites
  • Arena Oncology Associates

    Great Neck, New York, 11021

  • N.W. Carolina Oncology & Hematology, P.A.

    Hickory, North Carolina, 28603

  • Wilshire Oncology Medical Group, Inc.

    Los Angeles, California, 90057

  • Associates of Hematology/Oncology

    Upland, Pennsylvania, 19013

  • New York Medical College

    Valhalla, New York, 10595

  • Geffen Cancer Center and Research Institute

    Vero Beach, Florida, 32960-6541

Other trials in United States

About this study

Official title: A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have prostate cancer that has not responded to hormone therapy.

Read the detailed description

OBJECTIVES: I. Determine the PSA response, duration of PSA response, disease free survival, median survival, and overall survival in patients with chemotherapy naive hormone refractory adenocarcinoma of the prostate treated with doxorubicin and cyclophosphamide with sequential docetaxel. II. Assess for any improvement in pain over time in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive doxorubicin IV over 3-5 minutes and cyclophosphamide IV on days 1, 22, 43, and 64, and docetaxel IV over 1 hour on days 85, 106, and 127 in the absence of disease progression or unacceptable toxicity. Patients receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after completion of chemotherapy infusions and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to starting subsequent chemotherapy infusions. Pain and analgesic use are assessed before study, every 3 weeks during study, after completion of study, and then at 3 months after completion of study. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter until death.

PROJECTED ACCRUAL: Approximately 42-105 patients will be accrued for this study over 18 months.

Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer, pain
Medical subject headings
Pain, Prostatic Neoplasms

What participants receive

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

Timeline

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

  1. First posted8 Jun 2004 (estimated)
  2. Study startOct 1999

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005960
Sponsor's protocol ID
CDR0000067942
Other IDs
AMGEN-GCSF-980282, NCI-V00-1595
Status last verified
Jan 2001
First submitted
5 Jul 2000
Last updated
4 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, cyclophosphamide and docetaxel in people with Pain and Prostate Cancer, run by Amgen at 6 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: status not confirmed, as of the sponsor's last update on 4 Dec 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 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?

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.

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 4 Dec 2013.

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