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Spots Global Cancer Trial Database for Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

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Trial Identification

Brief Title: Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

Official Title: A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer

Study ID: NCT00093457

Conditions

Prostate Cancer

Interventions

sorafenib tosylate

Study Description

Brief Summary: RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.

Detailed Description: OBJECTIVES: * Determine the efficacy of sorafenib, as measured by prostate-specific antigen response, in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate. Secondary * Determine the objective response rate and duration of response in patients treated with this drug. * Determine the tolerability and toxicity of this drug in these patients. * Determine time to treatment failure and overall survival in patients treated with this drug. * Explore the relationship between measures of ras/raf pathway activation (pERK) and response to treatment in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks after going off study treatment and then periodically for survival. Patients with stable or responding disease, when they go off study treatment, are followed every 3 months until relapse or progression. PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study within 12-18 months.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada

British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, Canada

British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada

London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada

Princess Margaret Hospital, Toronto, Ontario, Canada

Contact Details

Name: Kim N. Chi, MD

Affiliation: British Columbia Cancer Agency

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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