| Exclusion Criteria: | 1) Sexually active fertile men not using effective birth control if their partners are WOCBP. Taxanes are considered to be teratogenic. For this reason men whose sexual partners are of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of study participation. Should a patient's sexual partner become pregnant or suspect she is pregnant while patient is participating in this study, the treating physician should be informed immediately.
2) Patients with known brain metastases are excluded from this clinical trial.
3) Clinically-significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc > 450 msec., Ejection Fraction (EF) < 40% or major conduction abnormality (unless a cardiac pacemaker is present).
4) Patients with a pleural or pericardial effusion will be excluded from this clinical trial as the combination of docetaxel and dasatinib may worsen this condition.
5) Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be enrolled into the study. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered (by their physician) to be at less than 30% risk for relapse.
6) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
7) Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel.
8) History of allergic reactions attributed to compounds of similar chemical or biologic composition to the investigational agents.
9) Patients may not be receiving any other investigational agents for the treatment of prostate cancer.
10) Patients may continue on a daily Multi-Vitamin but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before enrollment into the study.
11) Ketoconazole must be discontinued 4 weeks prior to enrollment.
12) Patients on stable doses of bisphosphonates, who develop subsequent tumor progression, may continue on this medication. However patients are not allowed to initiate bisphosphonate therapy immediately prior to or during the study, to avoid risk of hypocalcemia and confounding of bone effects by the simultaneous introduction of two new agents affecting bone.
13) Patients must not receive radioactive bone targeting agents such as Strontium or Samarian while on this protocol.
14) The following restrictions on prior therapy for metastatic disease apply: a) One chemotherapy regimen will be permitted, as long as docetaxel resistance or intolerance was not demonstrated. Docetaxel resistance is defined as objective disease progression or confirmed PSA progression during docetaxel therapy or within 3 months of treatment completion. Docetaxel intolerance is defined as toxicity requiring docetaxel interruption greater than 4 weeks or dose modification below approved doses. b) No more than one prior course of palliative radiotherapy.
15) (# 14 cont'd) c) Up to one prior treatment with a non-chemotherapeutic agent (e.g., kinase inhibitors, immunotherapeutic agents, etc) is permitted as treatment for metastatic prostate cancer. d) No prior radioisotope therapy with Strontium-89, Samarium or similar agents. e) No limitation on prior hormonal therapy.
16) Potent CYP 3A4 inhibitors and inducers or QTc prolonging agents strongly associated with Torsade de Pointes arrhythmia.
17) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study. |