Sutent Maintenance After Response to Taxotere

NCT00550810

Last updated date
Study Location
Tom Baker Cancer Centre
Calgary, Alberta, t4c 2h5, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer, Hormone Refractory
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

- Histological or cytological diagnosis of adenocarcinoma of the prostate

- Metastatic or locally recurrent disease not curable with standard therapy

- ECOG performance status 0, 1 or 2

- Prior single agent docetaxel or docetaxel combination chemotherapy with a documented PSA or imaging response, and no objective evidence of disease progression at study enrolment

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


- Patients with a history of other invasive cancer, except adequately treated non


- melanoma skin cancer.


- Patients with known brain metastases.


- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to SU011248.


- Other serious intercurrent illness or medical condition that might be aggravated by
protocol treatment.

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Prostate Cancer, Hormone RefractorySutent Maintenance After Response to Taxotere
NCT00550810
  1. Calgary, Alberta
  2. Edmonton, Alberta
  3. Vancouver, British Columbia
  4. London, Ontario
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sutent Maintenance After Response to Taxotere
Official Title  ICMJE A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy
Brief Summary

The major goal is to determine whether the experimental agent has clinically promising activity that would merit progression to a formal phase III trial.

Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no systemic treatment has been proven to be effective. Because of its action, safety and simple administration SU011248 has potential for effectiveness in this disease setting. Promising activity in this study would provide the necessary proof-of-principle for a larger confirmatory study in this population, and potentially in earlier stages of this common disease.

Detailed Description Not Provided
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
  • Hormone Refractory
Intervention  ICMJE Drug: Sunitinib (SU011248)
SU011248 (study medication) will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2 week rest period to form a complete cycle of 6 weeks. Study medication will be orally self administered once daily without regard to meals beginning on Day 1 of the study. Cycles will be repeated in the absence of unacceptable toxicity or disease progression
Other Name: Sutent
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: October 29, 2007)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2012
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological or cytological diagnosis of adenocarcinoma of the prostate
  • Metastatic or locally recurrent disease not curable with standard therapy
  • ECOG performance status 0, 1 or 2
  • Prior single agent docetaxel or docetaxel combination chemotherapy with a documented PSA or imaging response, and no objective evidence of disease progression at study enrolment

Exclusion Criteria:

  • Patients with a history of other invasive cancer, except adequately treated non
  • melanoma skin cancer.
  • Patients with known brain metastases.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to SU011248.
  • Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment.
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00550810
Other Study ID Numbers  ICMJE TBCC-0707001
SMART
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rachel Syme, Alberta Health Services
Study Sponsor  ICMJE Alberta Health Services
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Bernhard Eigl, M.D.Tom Baker Cancer Board
PRS Account AHS Cancer Control Alberta
Verification Date September 2011

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