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Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008

Sponsored by: University of Texas
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00348816
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: prednisone
Procedure: adjuvant therapy
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

ChemIDplus related topics:   Docetaxel    Prednisone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of prostate-specific antigen (PSA) decline [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival based on PSA progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Correlation between velocity of subsequent PSA failure and survival [ Designated as safety issue: No ]

Estimated Enrollment:   50
Study Start Date:   May 2006

Detailed Description:

OBJECTIVES:

Primary

  • Determine the rate of prostate-specific antigen (PSA) decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a rising PSA after radical prostatectomy.

Secondary

  • Determine the tolerability of this regimen in these patients.
  • Determine the progression-free survival, based on PSA progression, of these patients.
  • Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy.
  • Determine if the velocity of subsequent PSA failure impacts survival of these patients.

Tertiary

  • Document subsequent therapy for patients whose previous treatment has failed and if there is a response to that therapy.

OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and undergo external-beam radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.

Beginning within 6 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month, every 4 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer
  • Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago
  • No lymph node-positive prostate cancer
  • No documented metastatic disease

    • CT scan of the abdomen and pelvis negative (within the past 6 months)
    • No bone pain OR negative bone scan (within the past 6 months)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin normal
  • ALT and AST ≤ 1.5 times upper limit of normal
  • Alkaline phosphatase normal
  • Fertile patients must use effective contraception
  • No peripheral neuropathy > grade 1
  • No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer
  • No serious illness with a life expectancy of < 5 years
  • No concurrent medical, psychological, or social circumstance that would preclude study compliance
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior orchiectomy
  • No prior chemotherapy regimen for this disease
  • No prior pelvic radiotherapy
  • No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride

    • Preoperative androgen manipulation for a duration of ≤ 3 months allowed
  • No prior immunotherapy
  • No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent herbal or alternative regimens including, but not limited to, any of the following:

    • Saw palmetto
    • PC-SPES
    • Shark cartilage
  • No other concurrent investigational agents
  • No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348816

Locations
United States, Texas
University of Texas Health Science Center at San Antonio     Recruiting
      San Antonio, Texas, United States, 78229-3900
      Contact: Gregory P. Swanson, MD     210-450-5648        

Sponsors and Collaborators
University of Texas

Investigators
Study Chair:     Gregory P. Swanson, MD     University of Texas    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000486733, UTHSC-045-0015-377
First Received:   July 5, 2006
Last Updated:   August 20, 2008
ClinicalTrials.gov Identifier:   NCT00348816
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer  
stage II prostate cancer  
stage III prostate cancer  
stage IV prostate cancer  

Study placed in the following topic categories:
Docetaxel
Prednisone
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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