Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

Condition(s) targeted: Hormone Refractory Prostate Cancer

Intervention: Docetaxel * Sunitinib (Drug); Docetaxel (Drug); Docetaxel (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Michael MK Krainer, MD, Principal Investigator, Affiliation: Dept of Internal Medicine I, Medical University Vienna, Austria

Overall contact:
Michael MK Krainer, MD, Phone: +43 1 40400, Ext: 4445, Email: michael.krainer@meduniwien.ac.at

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

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

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

Primary outcome: Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy

Secondary outcome: Response rate and length of treatment holidays relative to docetaxel monotherapy

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Michael MK Krainer, MD, Phone: +43 1 40400, Ext: 4445, Email: michael.krainer@meduniwien.ac.at

Dept of Internal Medicine, Vienna 1090, Austria; Recruiting
Volker VW Wacheck, MD, Phone: +43 1 40400, Ext: 2989, Email: Volker.Wacheck@meduniwien.ac.at
Michael , MK Krainer, MD, Principal Investigator

Starting date: November 2008
Last updated: August 17, 2010