RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of prostate cancer by blocking blood flow to the tumor. Giving docetaxel together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with cetuximab and to see how well it works in treating patients with metastatic prostate cancer.
OBJECTIVES: * To assess the efficacy and safety of docetaxel and cetuximab in patients with docetaxel-resistant hormone-refractory prostate cancer OUTLINE: This is a multicenter study. Patients receive cetuximab IV once weekly and docetaxel IV on day 1 (3-week courses) or on days 1, 8, and 15 (4-week courses). Treatment repeats every 3 weeks for up to 8 courses or every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Cetuximab: 400 mg/m2 initial dose on day 1, then 250 mg/m2 weekly starting on day 8 \--- for max. 24 weeks or until progression or unacceptable toxicity ---
75 mg/m2 day 1 of a 21 day cycle or 35 mg/m2 day 1,8,15 of a 28 day cycle \--- for max. 24 weeks or until progression or unacceptable toxicity ---
Kantonspital Aarau
Aarau, Switzerland
Kantonsspital Baden
Baden, Switzerland
Saint Claraspital AG
Basel, Switzerland
Universitaetsspital-Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Spitalzentrum Biel
Biel, Switzerland
Kantonsspital Bruderholz
Bruderholz, Switzerland
AndreasKlinik Cham Zug
Cham, Switzerland
Kantonsspital Graubuenden
Chur, Switzerland
Kantonsspital Freiburg
Fribourg, Switzerland
...and 11 more locations
Progression-free survival (PFS)
Time frame: at 12 weeks
Progression-free survival (PFS)
Time frame: at 24 weeks
Adverse events
Time frame: All AEs will be assessed according to NCI CTCAE v3.0.
Prostate-specific antigen (PSA) response (30% and 50% PSA response)
Time frame: is defined as a decrease in PSA level of at least 50% (compared to baseline PSA) confirmed after 3-4 weeks (according to the PSA working group consensus criteria)
Tumor assessment of measurable disease according to RECIST criteria
Time frame: after 12 weeks of treatment, or earlier if clinically indicated
Tumor assessment of bone lesions
Time frame: at 12 weeks
Overall survival
Time frame: calculated from registration until death.
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