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Avastin, Docetaxel and Androgen Deprivation Followed by Continued Avastin and Androgen Deprivation for Men With a Rising PSA After Local Therapy

This study is currently recruiting participants.
Verified by Dana-Farber Cancer Institute, April 2008

Sponsors and Collaborators: Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Genentech
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00658697
  Purpose

In this research study, we are looking to see how Avastin works in combination with docetaxel and hormone therapy for men who have a rising PSA after treatment of their prostate cancer with surgery or radiation.


Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel
Drug: Avastin
Drug: Lupron or Zoladex
Drug: Bicalutamide
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

ChemIDplus related topics:   Docetaxel    Bevacizumab    Goserelin    Leuprolide acetate    Leuprolide    Bicalutamide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:   A Phase II Trial of Avastin, Docetaxel and Androgen Deprivation Followed by Continued Avastin and Androgen Deprivation for Men With a Rising PSA After Local Therapy

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Evaluate the proportion of patients free from PSA progression at one year off ADT. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA response as completion of docetaxel/Avastin, at completion of ADT and one year off ADT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation of PSA response and TTP [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Testosterone recovery at 6, 12 months off ADT [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   42
Study Start Date:   April 2008
Estimated Primary Completion Date:   April 2010 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Docetaxel
    Intravenously every three weeks for 4 cycles (total to 3 months)
    Drug: Avastin
    Intravenously every 3 weeks for a total of 17 cycles (total of 1 year)
    Drug: Lupron or Zoladex
    Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)
    Drug: Bicalutamide
    Starting on day 84 orally once daily until hormone therapy is completed
Detailed Description:
  • Each treatment cycle lasts three weeks. During the first three months, participants will receive the Avastin and docetaxel on day 1 of each three-week cycle for a total of four doses of docetaxel/Avastin. Avastin and docetaxel are administered intravenously. The Avastin will continue to be given every three weeks after the docetaxel is completed for a total of 17 doses (one year) of Avastin therapy.
  • Participants will receive zoladex (or lupron) on day 1 of the first cycle and then every 3 months for a total of 18 months. Zoladex is administered subcutaneously and Lupron is administered intramuscularly.
  • Bicalutamide pills will be started at the completion of docetaxel chemotherapy (start of month 4) and will be taken once daily until hormone therapy is completed (total of 15 months).
  • During all treatment cycles, the participant will have a physical exam and will be asked questions about their general health and specific questions about any problems they might be experiencing. Blood work will be performed every three weeks for the first three months and then every three months while on hormone therapy and during follow-up.
  • After the final treatment participants will have a follow-up visit every three months for the first two years, every 4 months for the third year and every 6 months for years 4 and 5.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 18 years of age or older
  • History of biopsy documented prostate cancer (any Gleason score)
  • Past treatment with prostatectomy with our without salvage prostate/pelvic radiation or primary radiation
  • If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
  • PSA recurrence with PSAdt 8 months or less. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be 2.0ng/ml or greater
  • No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis on CXR
  • Prior ADT allowed if less than 6 months and testosterone recovered to within 50 units of normal range
  • ECOG Performance status of 0-1
  • Absolute neutrophil count of 1,500 mm3 or greater
  • Platelet Count 100,000 mm3 or greater
  • Total bilirubin within normal limits
  • HG 8gm/dl or greater
  • Testosterone within 50 units of normal range
  • No history of bleeding or thromboses within the last 12 months that required medical intervention

Exclusion Criteria:

  • History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
  • Medical condition requiring concomitant corticosteroids
  • Active infection
  • Prior chemotherapy
  • Neuropathy requiring medical therapy
  • Documented local recurrence or metastatic prostate cancer
  • Inability to comply with study and/or follow-up procedures
  • Life expectancy of less than 2 years
  • Current, recent (within 4 weeks of first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
  • Inadequately controlled hypertension
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • NYHA Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 12 months prior to study enrollment
  • History of stroke or transient ischemic attack at any time
  • Known CNS disease
  • Significant vascular disease
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, ulcer, or bone fracture
  • Proteinuria at screening
  • Known hypersensitivity to any component of Avastin
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658697

Contacts
Contact: Mary-Ellen Taplin, MD     617-632-5092    
Contact: Gina Scibelli     617-632-5598    

Locations
United States, Massachusetts
Dana-Farber Cancer Institute     Recruiting
      Boston, Massachusetts, United States, 02115
      Principal Investigator: Mary-Ellen Taplin, MD            
Beth Israel Deaconess Medical Center     Recruiting
      Boston, Massachusetts, United States, 02115
      Principal Investigator: Glenn Bubley, MD            

Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Genentech

Investigators
Principal Investigator:     Mary-Ellen Taplin, MD     Dana-Farber Cancer Institute    
  More Information


Responsible Party:   Dana-Farber Cancer Institute ( Mary-Ellen Taplin, MD )
Study ID Numbers:   08-004
First Received:   April 9, 2008
Last Updated:   April 9, 2008
ClinicalTrials.gov Identifier:   NCT00658697
Health Authority:   United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Rising PSA  
androgen deprivation  
avastin  
docetaxel  
lupron
zoladex
bicalutamide

Study placed in the following topic categories:
Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Goserelin
Bicalutamide
Urogenital Neoplasms
Bevacizumab
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 17, 2008




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