Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00795171

Purpose

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

Condition	Intervention	Phase
Hormone Refractory Prostate Cancer	Drug: Docetaxel * Sunitinib Drug: Docetaxel	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Randomized, Controlled Biomarker Study Evaluating the Anti-Angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Response rate and length of treatment holidays relative to docetaxel monotherapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator docetaxel 75mg/m2 day1 q 21d x 4 cycles	Drug: Docetaxel docetaxel 75mg/m2 day1 q 21d x 4 cycles

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795171

Contacts

Contact: Michael MK Krainer, MD

+43 1 40400 ext 4445

michael.krainer@meduniwien.ac.at

Locations

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

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Michael MK Krainer, MD

Dept of Internal Medicine I, Medical University Vienna, Austria

More Information

Responsible Party:	Medical University Vienna, Austria ( Dept of Internal Medicine I, Medical University Vienna, Austria )
Study ID Numbers:	MK URO 4, EUDRACT 2007-003705-27
Study First Received:	November 20, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795171
Health Authority:	Austria: AGES

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Sunitinib

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009