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
Recruitment status was Recruiting
Sponsor:
Medical University of Vienna
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
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel |
Resource links provided by NLM:
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: | July 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Taxotere
Drug: Docetaxel
Docetaxel 75mg/m2 q21d for 4 cycles
Other Name: Taxotere
|
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: | No |
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
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
No publications provided
| Responsible Party: | Dept of Internal Medicine I, Medical University Vienna, Austria, Medical University Vienna, Austria |
| ClinicalTrials.gov Identifier: | NCT00795171 History of Changes |
| Other Study ID Numbers: | MK URO 4, EUDRACT 2007-003705-27 |
| Study First Received: | November 20, 2008 |
| Last Updated: | August 17, 2010 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Docetaxel Sunitinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013