Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

Hormone Refractory Prostate Cancer Clinical Trial

Official title:

Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00795171
• Other study ID #: MK URO 4
• Secondary ID: EUDRACT 2007-003
• Status: Recruiting
• Phase: Phase 2
• First received: November 20, 2008
• Last updated: August 17, 2010
• Start date: November 2008
• Est. completion date: July 2011

Study information

• Verified date: August 2010
• Source: Medical University of Vienna
• Contact: Michael MK Krainer, MD
• Phone: +43 1 40400
• Email: michael.krainer[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients

Description:

Docetaxel (75mg/m2 q21d) is standard of care for patients with hormone refractory prostate cancer (HRPC). Recent data indicate, that chemotherapeutics given at MTD induce, besides their cytotoxic effects, mobilization of circulating endothelial cells (CEC) and - progenitors (CEP) in drug-free breaks of each cycle. In preclinical models, mobilized CEC/CEP result in tumor vasculogenesis and progression of disease.

We hypothesize that treatment with sunitinib, an anti-angiogenic tyrosine kinase inhibitor, in between 3 weekly docetaxel disrupts CEC/CEP spikes following docetaxel leading to chemosensitization and reduced tumor re-growth in HRPC patients responding to docetaxel.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• WHO performance status of 0-2.

• Histologically proven prostate adenocarcinoma.

• All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression

• Measurable and/or evaluable progressive disease, which is defined by one of the following three criteria:

• 25% increase in bidimensionally measurable soft tissue metastases

• Appearance of new metastatic lesions (proven by CT scan, X-ray or bone scan)

• PSA level of at least 10ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart

• If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization

Exclusion Criteria:

• prior chemotherapy for prostate cancer

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hormone Refractory Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel * Sunitinib
docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
• Docetaxel
docetaxel 75mg/m2 day1 q 21d x 4 cycles
• Docetaxel
Docetaxel 75mg/m2 q21d for 4 cycles

Locations

Country	Name	City	State
Austria	Dept of Internal Medicine	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy		12 weeks	No
Secondary	Response rate and length of treatment holidays relative to docetaxel monotherapy		6 months	No