Sutent Maintenance After Response to Taxotere - Full Text View

Sponsor:	Alberta Health Services
Collaborator:	Pfizer
Information provided by:	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00550810

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer Hormone Refractory	Drug: Sunitinib (SU011248)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Historical Control Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of SU011248 for Maintenance Therapy in Hormone Refractory Prostate Cancer After First Line Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: 180 days without evidence of disease progression would be considered clinically worthy of further investigation ]

Secondary Outcome Measures:

-PSA Response -Toxicity [ Time Frame: The secondary endpoint of PSA response will also be documented. PSA response is defined as a ≥50% fall in PSA (minimum of 5 µg/L) from baseline maintained for > 3 weeks and without evidence of disease progression otherwise. ]

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2009

Intervention Details:

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

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550810

Contacts

Contact: Samantha Billingsley, BHSc, CCRP

403-521-3678

Samantha.Billingsley@albertahealthservices.ca

Locations

Canada, Alberta
Tom Baker Cancer Centre	Recruiting
Calgary, Alberta, Canada, t4c 2h5
Contact: Bernie Eigl, M.D. 403-521-3347 Bernie.Eigl@albertahealthservices.ca
Contact: Samantha Billingsley, BHSc, CCRP 403-521-3678 Samantha.Billlingsley@albertahealthservices.ca
Principal Investigator: Bernhard Eigl, M.D.
Cross Cancer Institute	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Scott North, M.D. 780-432-8762 Scott.North@albertahealthservices.ca
Contact: Maureen Lesiuk 780-432-8349 maureen.lesiuk@albertahealthservices.ca
Principal Investigator: Scott North, M.D.
Canada, British Columbia
Vancouver Cancer Centre	Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Kim Chi, M.D. 604-877-6000 kchi@bccancer.bc.ca
Principal Investigator: Kim Chi, M.D.
Canada, Ontario
London Health Sciences Centre	Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Eric Winquist, M.D. 519-685-8600 eric.winquist@lhsc.on.ca

Sponsors and Collaborators

Alberta Health Services

Pfizer

Investigators

Study Chair:

Bernhard Eigl, M.D.

Tom Baker Cancer Board

More Information

No publications provided

Responsible Party:	Tom Baker Cancer Centre ( Dr. Bernhard Eigl )
ClinicalTrials.gov Identifier:	NCT00550810 History of Changes
Other Study ID Numbers:	TBCC-0707001, SMART
Study First Received:	October 26, 2007
Last Updated:	July 27, 2010
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Health Services:

Sutent

Additional relevant MeSH terms:

Sunitinib
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 01, 2010