Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00795171
First received: November 20, 2008
Last updated: August 17, 2010
Last verified: August 2010

November 20, 2008
August 17, 2010
November 2008
April 2011   (final data collection date for primary outcome measure)
Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00795171 on ClinicalTrials.gov Archive Site
Response rate and length of treatment holidays relative to docetaxel monotherapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer
Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel

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

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Hormone Refractory Prostate Cancer
  • Drug: Docetaxel * Sunitinib
    docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
    Other Name: Taxotere + Sutent
  • Drug: Docetaxel
    docetaxel 75mg/m2 day1 q 21d x 4 cycles
    Other Name: Taxotere
  • Drug: Docetaxel
    Docetaxel 75mg/m2 q21d for 4 cycles
    Other Name: Taxotere
  • Experimental: Docetaxel + Sunitinib
    docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
    Intervention: Drug: Docetaxel * Sunitinib
  • Active Comparator: Taxotere
    docetaxel 75mg/m2 day1 q 21d x 4 cycles
    Interventions:
    • Drug: Docetaxel
    • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2011
April 2011   (final data collection date for primary outcome measure)

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

Male
18 Years and older
No
Contact: Michael MK Krainer, MD +43 1 40400 ext 4445 michael.krainer@meduniwien.ac.at
Austria
 
NCT00795171
MK URO 4, EUDRACT 2007-003705-27
No
Dept of Internal Medicine I, Medical University Vienna, Austria, Medical University Vienna, Austria
Medical University of Vienna
Not Provided
Principal Investigator: Michael MK Krainer, MD Dept of Internal Medicine I, Medical University Vienna, Austria
Medical University of Vienna
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP