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

NCT00215345

Last updated date
Study Location
Department Of Veterans Affairs NJ Health Care System
East Orange, New Jersey, 07018, United States
Contact
973-676-1000

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

973-676-1000

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Prostate CancerA Study of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Prostate Cancer
NCT00218205
  1. East Orange, New Jersey
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerMultimodality Phase II Study in Prostate Cancer
NCT00734851
  1. Baltimore, Maryland
  2. New Brunswick, New Jersey
  3. Durham, North Carolina
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerStudy on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
NCT02918968
  1. Nagoya, Aichi
  2. Nagoya, Aichi
  3. Matsuyama, Ehime
  4. Iizuka, Fukuoka
  5. Isesaki, Gunma
  6. Maebashi, Gunma
  7. Ota, Gunma
  8. Hakodate, Hokkaido
  9. Sapporo, Hokkaido
  10. Sapporo, Hokkaido
  11. Sapporo, Hokkaido
  12. Mito, Ibaraki
  13. Sagamihara, Kanagawa
  14. Yokohama, Kanagawa
  15. Yokohama, Kanagawa
  16. Yokosuka, Kanagawa
  17. Kashihara, Nara
  18. Kurashiki, Okayama
  19. Hirakata, Osaka
  20. Osakasayama, Osaka
  21. Suita, Osaka
  22. Kitaadachi-gun, Saitama
  23. Hamamatsu, Shizuoka
  24. Utsunomiya, Tochigi
  25. Bunkyo-ku, Tokyo
  26. Bunkyo-ku, Tokyo
  27. Koto-ku, Tokyo
  28. Nakano-ku, Tokyo
  29. Shinagawa-ku, Tokyo
  30. Shinjuku-ku, Tokyo
  31. Ube, Yamaguchi
  32. Chiba,
  33. Chiba,
  34. Fukuoka,
  35. Fukuoka,
  36. Fukuoka,
  37. Hiroshima,
  38. Kyoto,
  39. Nagano,
  40. Nagano,
  41. Nagasaki,
  42. Osaka,
  43. Osaka,
  44. Osaka,
  45. Saga,
  46. Tokushima,
  47. Toyama,
Male
20 Years+
years
MULTIPLE SITES
Prostate CancerPalbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT02905318
  1. Edmonton, Alberta
  2. Vancouver, British Columbia
  3. Halifax, Nova Scotia
  4. Hamilton, Ontario
  5. London, Ontario
  6. Ottawa, Ontario
  7. Toronto, Ontario
  8. Montreal, Quebec
  9. Montreal, Quebec
  10. Regina, Saskatchewan
  11. Saskatoon, Saskatchewan
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase II Trial of Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer
Official Title  ICMJE A Phase II Trial of Combination Therapy With Celecoxib and Taxotere for the Treatment of Stage D3 Prostate Cancer
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Taxotere
  • Drug: Celecoxib
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 20, 2005)
66
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • Patients with a history of severe hypersensitivity to Taxotere or other drugs formulated with polysorbate 80 must be excluded
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00215345
Other Study ID Numbers  ICMJE COXAON-0509-047
GIA16125
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Department of Veterans Affairs, New Jersey
Collaborators  ICMJE
  • Pfizer
  • Sanofi
Investigators  ICMJE
Principal Investigator:Basil Kasimis, MDDepartment of Veterans Affairs NJ Health Care System
PRS Account Department of Veterans Affairs, New Jersey
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP