Sutent Maintenance After Response to Taxotere

NCT00550810 | Unknown Phase 2 DMC

• 2 other identifiers: TBCC-0707001SMART
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer; Hormone Refractory

Keywords

Sutent

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  180 days without evidence of disease progression would be considered clinically worthy of further investigation

Secondary Outcomes (1)

• -PSA Response -Toxicity

  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.

Interventions

Sunitinib (SU011248) DRUG

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

Also known as: Sutent

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alberta Health services: lead
• Pfizer: collaborator

Study Sites (4)

Tom Baker Cancer Centre

Calgary, Alberta, t4c 2h5, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bernhard Eigl, M.D.

  Tom Baker Cancer Board

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Bernie Eigl

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 30, 2007
• Study Start: October 1, 2007
• Study Completion: November 1, 2012
• Last Updated: December 7, 2011

Record last verified: 2011-09

Locations

CA (4)