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Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

Primary Purpose

Hormone Refractory Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Docetaxel * Sunitinib
Docetaxel
Docetaxel
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hormone Refractory Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Internal MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Docetaxel + Sunitinib

Taxotere

Arm Description

docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles

docetaxel 75mg/m2 day1 q 21d x 4 cycles

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response rate and length of treatment holidays relative to docetaxel monotherapy

Full Information

First Posted
November 20, 2008
Last Updated
August 17, 2010
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00795171
Brief Title
Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer
Official Title
Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Refractory Prostate Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel + Sunitinib
Arm Type
Experimental
Arm Description
docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
Arm Title
Taxotere
Arm Type
Active Comparator
Arm Description
docetaxel 75mg/m2 day1 q 21d x 4 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel * Sunitinib
Other Intervention Name(s)
Taxotere + Sutent
Intervention Description
docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
docetaxel 75mg/m2 day1 q 21d x 4 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 75mg/m2 q21d for 4 cycles
Primary Outcome Measure Information:
Title
Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Response rate and length of treatment holidays relative to docetaxel monotherapy
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael MK Krainer, MD
Phone
+43 1 40400
Ext
4445
Email
michael.krainer@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael MK Krainer, MD
Organizational Affiliation
Dept of Internal Medicine I, Medical University Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Internal Medicine
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker VW Wacheck, MD
Phone
+43 1 40400
Ext
2989
Email
Volker.Wacheck@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Michael, MK Krainer, MD

12. IPD Sharing Statement

Learn more about this trial

Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

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