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Keep this study
Lead
Bayer
With
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age greater than or equal to 18 years
Advanced histological or cytological documentation of cancer
At least one evaluable lesion
ECOG Performance Status of 0 or 1
No more than one prior chemotherapy regimen (prior adjuvant therapy, immunotherapy or hormone treatment are allowed and not restricted)
Life expectancy of at least 12 weeks
No previous exposure to docetaxel or sorafenib
Adequate bone marrow, liver and renal function as assessed by the following:
* Hemoglobin greater than or equal to 9.0 g/dL
* Absolute neutrophil count (ANC) greater than or equal to 2,500/mm3
* Platelet count greater than or equal to 100,000/mm3 Hepatic
* Total Bilirubin less than or equal to ULN
* AST, ALT and Alkaline Phosphatase less than 1.5x ULN.
* PT-INR/PTT less than 1.5 x ULN (Patients who are being prophylactically anti coagulated with an agent such as coumadin or heparin will be allowed to participate provided that the INR less than 1.5. In addition, these patients must be monitored at appropriate intervals throughout study)
* Serum creatinine less than or equal to 1.5 x upper limit of normal
You may not be if
Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
Active clinically serious infections (\> Grade 2 NCI-CTCAE Version 3.0)
Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Peripheral neuropathy \> Grade 1
Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to screening
Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment
Pregnant or breast feeding women
Clareo Health | Sorafenib/Docetaxel Dose Escalation Trial
