Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

Medical University of Vienna

Status and phase: Unknown; Phase 2

Conditions: Hormone Refractory Prostate Cancer

Treatments: Drug: Docetaxel; Drug: Docetaxel * Sunitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT00795171

EUDRACT 2007-003705-27

MK URO 4

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Docetaxel + Sunitinib

Experimental group

Description:

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

Treatment:

Drug: Docetaxel * Sunitinib

Taxotere

Active Comparator group

Description:

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

Treatment:

Drug: Docetaxel

Drug: Docetaxel