Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate. Note: Patients may have either measurable or non-measurable disease.
Radiographic evidence of regional or distant metastases
Current evidence of progression (by PSA and/or imaging studies) despite standard hormonal therapy.
Progression by PSA will be defined as: A rising PSA defined as: at least 2 rises in PSA over a reference value (PSA #1). The first rising PSA (PSA #2) must be taken at least 1 week after PSA #1. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2. Progression for nonmeasurable disease will be defined as 2 or more new bone lesions; for measurable disease, progression will be defined by standard RECIST criteria.
For patients who have been on antiandrogen therapy (ie, bicalutamide, flutamide, etc.), patients must have discontinued anti-androgen therapy for at least 6 weeks (4 weeks for flutamide) without evidence of an antiandrogen withdrawal response. A washout period will not be required for patients who did not respond to an antiandrogen prescribed as second line hormonal therapy. For patients whose progression is documented by PSA, the last required PSA must be after the required anti-androgen washout period (4-6 weeks as appropriate).
One prior docetaxel-containing regimen. Patients must have received at least 2 doses in an every 3-week schedule or 6 doses on a weekly schedule of docetaxel. Patients may have discontinued therapy due to progression, intolerance, completion of planned therapy, or other reasons. Chemotherapy treatment with any second-line regimen will not be permitted. Patients who have been previously treated with a first-line docetaxel-based doublet regimen will be eligible for this study, (eg, patients treated on a prior first-line trial containing a docetaxel/carboplatin or other docetaxel-based doublet).
Serum testosterone levels (See protocol for specific details) (unless surgically castrate). Patients must continue androgen deprivation with an LHRH agonist if they have not undergone orchiectomy
ECOG performance status

Laboratory criteria for entry:

absolute neutrophil count
platelets
bilirubin
AST or ALT
Life expectancy greater than 3 months
Age greater than or equal to 18 years
Agree to use contraceptives while on study if sexually active, and for 2 months after the last dose of study drug.
Has signed a Patient Informed Consent Form
Has signed a Patient Authorization Form

Exclusion Criteria:

More than 1 prior chemotherapy regimen for metastatic disease
Prior history of uncontrolled congestive heart failure or left ventricular ejection fraction (LVEF) that is less than the institution's lower limit of normal on MUGA or echocardiogram
A second active malignancy (diagnosed within 5 years) except adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm
Significant active concurrent medical illness or infection
Treatment with chemotherapy for AIPC within the past 21 days
Prior treatment with Novantrone (mitoxantrone)
Prior therapy which specifically and directly targets the EGFR pathway
Prior severe infusion reaction to a monoclonal antibody
Recent myocardial infarction (within prior 6 months)
Prior treatment with radionuclides, with the exception of prior treatment with samarium, which will be allowed provided at least 8 weeks have passed since administration.
Is receiving concurrent immunotherapy, hormonal therapy, radiation therapy, or any other non-protocol therapy (excluding LHRH antagonist)
Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
Has evidence of CNS involvement
Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
Is unable to comply with requirements of study