Know Cancer

or
forgot password

Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Hormone Refractory Prostate Cancer

Thank you

Trial Information

Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Michael MK Krainer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept of Internal Medicine I, Medical University Vienna, Austria

Authority:

Austria: Agency for Health and Food Safety

Study ID:

MK URO 4

NCT ID:

NCT00795171

Start Date:

November 2008

Completion Date:

July 2011

Related Keywords:

  • Hormone Refractory Prostate Cancer
  • Prostatic Neoplasms

Name

Location