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Prostate CancerPhase 2NCT00215345

A Phase II Trial of Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer

A Phase 2 study testing Taxotere and Celecoxib in people with Prostate Cancer, run by Department of Veterans Affairs, New Jersey at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this clinical trial is to find out the safety and effectiveness as well as patient's quality of life on the combination of Taxotere and celecoxib on patients with hormone refractory prostate cancer. Celecoxib (Celebrex) is an FDA approved drug to treat arthritis. 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?
Taxotere and Celecoxib
How many people
66 participants
Where
1 siteUnited States
Study dates
Aug 2002to Dec 2006
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

Who may be able to join

  • Patient must have histologically proven adenocarcinoma of the prostate gland.
  • Patient must have evidence of progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases) within 6 weeks prior to participation in the study.
  • Patients who have evaluable but not measurable disease must not have an elevated PSA level as the only evidence of disease. While castrated, the patients should have rising PSA on two consecutive measurements at least 1 week apart. The confirmatory PSA must be obtained within 1 week prior to study registration and should be >10ng/ml.
  • Patients with bone metastases only (i.e., lacking soft-tissue disease) must have a PSA level of > 10 ng/ml. Patients with soft tissue metastases and /or visceral disease must have either measurable disease or a PSA level of > 10 ng/ml.
  • Radiological evidence of hydronephrosis will not by itself constitute evidence of metastatic disease.
  • Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g., estrogen therapy, LHRH analog + flutamide, etc.) with evidence of treatment failure.
Show all 24Show fewer
  • NOTE: patients who have not undergone bilateral orchiectomy must continue LHRH agonist therapy (e.g., depot leuprolide or goserelin) while receiving this protocol therapy. For these patients the testosterone level should be preferably checked before enrollment and should be < 50 ng/dl.
  • For patients previously treated with flutamide (Eulexin), nilutamide (Nilandron), or bicalutamide (Casodex): Patients must have discontinued flutamide or nilutamide < 4 weeks and for bicalutamide 6 weeks prior to registration.
  • Patients must not have received prior treatment with chemotherapy within the last 5 years.
  • Patients must not have had prior radiotherapy < 4 weeks prior to this protocol treatment.
  • Patients must not have previously received Strontium 89, Samarium 153, or other radioisotope therapies.
  • Patients must have recovered from all toxicities due to prior treatment for prostate cancer prior to receiving this protocol treatment.
  • Patients must have adequate bone marrow function: (WBC > 4000/ mm3, granulocytes > 1500/ mm3, platelet count > 100,000/mm3, and Hemoglobin > 8.0 g/dl < 4 weeks prior to participate in this study.
  • Patients must have the following chemistry values < 4 weeks prior to participate in this study:
  • Total bilirubin must be within normal limits.
  • Creatinine < 2.0 mg/d. or creatinine clearance > 50 ml/min
  • Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphastase is < ULN, or alkaline phosphastase may be up to 4 x ULN if transaminases are < ULN.
  • Peripheral neuropathy must be < grade 1
  • Patients must have no active angina pectoris, or known heart disease of New York Heart Association Class III-IV. Patients must not have a history of myocardial infarction < 6 months prior to the study participation.
  • Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for the specific cancer.
  • No serious concurrent medical illness or active infection should be present which would jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety.
  • Sexually active patients must use an accepted and effective method of contraception while receiving protocol treatment.
  • Patients must have a Karnofsky Performance Scale (KPS) score over 50. (equaling ECOG Performance Scale of 0, 1, or 2).
  • Age > 18 years

Who cannot join

  • Patients with a history of severe hypersensitivity to Taxotere or other drugs formulated with polysorbate 80 must be excluded

Trial locations and contacts

1 site in 1 country.

Basil Kasimis, MD contact

973-676-1000 ext. 1544

basil.kasimis@med.va.gov

United States1 site, 1 recruiting

  • Department Of Veterans Affairs NJ Health Care System

    East Orange, New Jersey, 07018

    Basil Kasimis, MD, 973-676-1000 ext. 1544, basil.kasimis@med.va.gov

    Victor Chang, MD

    Recruiting

Other trials in United States

About this study

The purpose of this clinical trial is to find out the safety and effectiveness as well as patient's quality of life on the combination of Taxotere and celecoxib on patients with hormone refractory prostate cancer. Celecoxib (Celebrex) is an FDA approved drug to treat arthritis. Taxotere (Docetaxel) is an FDA approved chemotherapy drug to treat certain forms of cancer. Both drugs have demonstrated evidences of tumor blood vessel suppression and combination of these two drugs could possibly arrest further tumor growth or make the tumor decrease in size.

Read the detailed description

The standard hormone therapy for patients with metastases is androgen deprivation. This treatment leads to response in 75-80% of the patients, with median duration of response of only 14-18 months. Once the patient becomes hormone resistant, there is no effective therapy to prolong life. For patients with HRPC, the median life expectancy is 17 months.2 Thus palliative care remains the standard therapy for HRPC. The most widely used chemotherapy regimens are combinations of mitoxantrone with prednisone and taxanes with estramustine phosphate.3,4,5 Taxotere has also demonstrated activity in prostate cancer cell lines.6 Several clinical studies have demonstrated its activity in patients with metastatic prostate cancer as a single agent or in combination.4, 5 Taxotere may exert its effects in part through anti-angiogenic effects.7 Recent work in animal models has provided additional evidence for the beneficial role of angiostatic agents in the treatment of malignant diseases. This is the first study of the two drugs used together in prostate cancer.

Conditions
Prostate Cancer
Being tested
Taxotere, Celecoxib
Keywords
Celecoxib, Taxotere, Hormone Refractory 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.

What is being measured

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

  1. Determine the effect of Taxotere and celecoxib on PSA and objective response in patients with HRPC

Secondary outcomes (3)

  1. Evaluate the toxicity of the combination of celecoxib and Taxotere in patients with stage D3 prostate cancer.

  2. Determine the effects of this regimen on quality of life.

  3. Determine the survival of the patients treated

Timeline

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

  1. First posted22 Sep 2005 (estimated)
  2. Study startAug 2002
  3. Study completionDec 2006

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
66 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00215345
Sponsor's protocol ID
COXAON-0509-047
Other IDs
GIA16125
Status last verified
Sep 2005
First submitted
20 Sep 2005
Last updated
22 Sep 2005
Results posted
No

Publications

  • Kasimis B, Cogswell J, Hwang S, Chang VT, Srinivas S, Zhong F, Duque L, Morales E, Boholli I, Blumenfrucht M: High Dose Celecoxib © and Docetaxel (D) in Patients (pts) with Hormone Resistant Prostate Cancer (HRPC). Results of an Ongoing Phase II Trial Proc Am Soc Clin Oncol, Vol 24#4704, 2005

  • Yudd M, Kasimis B, Hwang S, Stanislaus G, Mcdowall S, Haastrup A, Penix J, Boholli I, Xia Q, Nazha N: Renal Effects of High Dose Celecoxib © during 2 Phase II Trials for Hormone Resistant Prostate Cancer (HRPC) Proc Am Soc Clin Oncol, Vol 24# 4751, 2005.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Taxotere and Celecoxib in people with Prostate Cancer, run by Department of Veterans Affairs, New Jersey 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 24 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Sep 2005. 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?

Results are not available in the source record.

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

Contact Basil Kasimis, MD (973-676-1000 ext. 1544, basil.kasimis@med.va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the effect of Taxotere and celecoxib on PSA and objective response in patients with HRPC. 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 NCT00215345, which also lists 2 linked publications.

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 22 Sep 2005.

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