Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

Phase 2

• Conditions: Hormone Refractory Prostate Cancer
• Interventions: Drug: Docetaxel * Sunitinib; Drug: Docetaxel

• Registration Number: NCT00795171
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-17
• Last Update Posted: 2010-08-18
• Primary Completion: 2011-04
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel + Sunitinib	Docetaxel * Sunitinib	docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
Taxotere	Docetaxel	docetaxel 75mg/m2 day1 q 21d x 4 cycles

Primary Outcome Measures

Name	Time	Method
Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy	12 weeks

Secondary Outcome Measures

Name	Time	Method
Response rate and length of treatment holidays relative to docetaxel monotherapy	6 months

Trial Locations

Locations (1)

Dept of Internal Medicine; 🇦🇹 Vienna, Austria