A Phase II Trial of Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer
2 other identifiers
interventional
66
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started Aug 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedSeptember 22, 2005
September 1, 2005
September 20, 2005
September 20, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the effect of Taxotere and celecoxib on PSA and objective response in patients with HRPC
Secondary Outcomes (3)
Evaluate the toxicity of the combination of celecoxib and Taxotere in patients with stage D3 prostate cancer.
Determine the effects of this regimen on quality of life.
Determine the survival of the patients treated
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +9 more criteria
You may not qualify if:
- Patients with a history of severe hypersensitivity to Taxotere or other drugs formulated with polysorbate 80 must be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Department of Veterans Affairs, New Jerseylead
- Pfizercollaborator
- Sanoficollaborator
Study Sites (1)
Department Of Veterans Affairs NJ Health Care System
East Orange, New Jersey, 07018, United States
Related Publications (2)
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
RESULTYudd 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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Basil Kasimis, MD
Department of Veterans Affairs NJ Health Care System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
August 1, 2002
Study Completion
December 1, 2006
Last Updated
September 22, 2005
Record last verified: 2005-09