Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

August 17, 2010 updated by: Medical University of Vienna

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Dept of Internal Medicine
        • Contact:
        • Principal Investigator:
          • Michael, MK Krainer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel + Sunitinib
docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
Drug: Docetaxel * Sunitinib
docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
Other Names:
  • Taxotere + Sutent
Active Comparator: Taxotere
docetaxel 75mg/m2 day1 q 21d x 4 cycles
Drug: Docetaxel
docetaxel 75mg/m2 day1 q 21d x 4 cycles
Other Names:
  • Taxotere
Drug: Docetaxel
Docetaxel 75mg/m2 q21d for 4 cycles
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate and length of treatment holidays relative to docetaxel monotherapy
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Michael MK Krainer, MD, Dept of Internal Medicine I, Medical University Vienna, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

August 18, 2010

Last Update Submitted That Met QC Criteria

August 17, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK URO 4
  • EUDRACT 2007-003705-27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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