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Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016913
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, hormone therapy, and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: carboplatin
Drug: estramustine phosphate sodium
Drug: goserelin
Drug: leuprolide acetate
Drug: paclitaxel
Procedure: neoadjuvant therapy
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Carboplatin    Paclitaxel    Estramustine    Estramustine phosphate    Estramustine phosphate sodium    Goserelin    Leuprolide acetate    Leuprolide    Phenylephrine    Guaifenesin    Naphazoline    Naphazoline hydrochloride    Oxymetazoline    Oxymetazoline hydrochloride    Phenylephrine hydrochloride    Phenylpropanolamine    Phenylpropanolamine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase II Study Of Neo-Adjuvant Paclitaxel, Estramustine And Carboplatin (TEC) Plus Androgen Ablation Prior To Radiation Therapy In Patients With Poor Prognosis Localized Prostate Cancer

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

Primary Outcome Measures:
  • Acute and late toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to prostate-specific antigen failure [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:   60
Study Start Date:   May 2001

Detailed Description:

OBJECTIVES:

  • Determine the feasibility and safety of paclitaxel, estramustine, carboplatin, and androgen ablation followed by radiotherapy in patients with poor-prognosis locally advanced prostate cancer.
  • Determine the progression-free survival and time to prostate specific antigen failure in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 1 hour once weekly; oral estramustine three times a day, five days a week; and carboplatin IV over 1 hour once monthly. Treatment repeats every 4 weeks for 4 courses.

Patients also receive gonadotropin-releasing hormonal therapy comprising either goserelin subcutaneously or leuprolide intramuscularly once monthly. Treatment repeats every 4 weeks for 6 courses.

After the completion of chemotherapy, patients undergo radiotherapy once daily on weeks 17-24.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.

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

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate with one of the following prognostic factors:

    • Tx N0, baseline prostate specific antigen (PSA) greater than 20 ng/mL, and Gleason score at least 7
    • T3b-4 N0, any baseline PSA, and any Gleason score
  • No pelvic lymph node disease requiring pelvic radiotherapy
  • No metastatic disease by bone scan, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 1.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No significant cardiovascular disease
  • No New York Heart Association class III or IV congestive heart failure
  • No active angina pectoris
  • No myocardial infarction within the past 6 months
  • No history of hemorrhagic or thrombotic cerebral vascular accident
  • No deep vein thrombosis within the past 6 months

Pulmonary:

  • No pulmonary embolism within the past 6 months

Other:

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for prostate cancer
  • No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy:

  • No prior chemotherapy for prostate cancer
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • No more than 6 weeks of prior androgen deprivation therapy
  • No other concurrent anticancer hormonal therapy except steroids for adrenal failure and/or hormones for nondisease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for prostate cancer
  • No other concurrent anticancer radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • No prior alternative therapy (e.g., PC-SPES) for prostate cancer
  • No concurrent alternative medicine (e.g., PC-SPES or saw palmetto) or large quantities of vitamins
  • No other concurrent anticancer therapy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016913

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center    
      Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center    
      Washington, District of Columbia, United States, 20307-5001
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center    
      Baltimore, Maryland, United States, 21201
Veterans Affairs Medical Center - Baltimore    
      Baltimore, Maryland, United States, 21201
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus    
      Worcester, Massachusetts, United States, 01655
United States, Missouri
Saint Luke's Hospital    
      Chesterfield, Missouri, United States, 63017
United States, Nevada
CCOP - Nevada Cancer Research Foundation    
      Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada    
      Las Vegas, Nevada, United States, 89102
United States, New York
CCOP - Hematology-Oncology Associates of Central New York    
      Syracuse, New York, United States, 13057
Community General Hospital of Greater Syracuse    
      Syracuse, New York, United States, 13215
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021
Oswego Hospital    
      Oswego, New York, United States, 13126
SUNY Upstate Medical University Hospital    
      Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Syracuse    
      Syracuse, New York, United States, 13210
United States, North Carolina
Lenoir Memorial Cancer Center    
      Kinston, North Carolina, United States, 28501
Wayne Memorial Hospital, Incorporated    
      Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology    
      Goldsboro, North Carolina, United States, 27534
Wilson Medical Center    
      Wilson, North Carolina, United States, 27893-3428
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University    
      Columbus, Ohio, United States, 43210-1240
United States, South Carolina
Bon Secours St. Francis Health System    
      Greenville, South Carolina, United States, 29601
CCOP - Greenville    
      Greenville, South Carolina, United States, 29615
Roper St. Francis Cancer Center at Roper Hospital    
      Charleston, South Carolina, United States, 29401
United States, Virginia
Danville Regional Medical Center    
      Danville, Virginia, United States, 24541

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     William K. Kelly, DO     Yale University    
  More Information


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

Publications of Results:

Study ID Numbers:   CDR0000068632, CALGB-99811
First Received:   June 6, 2001
Last Updated:   November 11, 2008
ClinicalTrials.gov Identifier:   NCT00016913
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate  
stage III prostate cancer  

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Estramustine
Goserelin
Urogenital Neoplasms
Carboplatin
Genital Diseases, Male
Naphazoline
Oxymetazoline
Guaifenesin
Paclitaxel
Leuprolide
Phenylephrine
Phenylpropanolamine
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Reproductive Control Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Fertility Agents, Female
Tubulin Modulators
Fertility Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on November 19, 2008




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