A Phase I Dose Escalation Study With Sorafenib Administered Continuously in Combination With Docetaxel Administered Once Every Three Weeks in Patients With Advanced Solid Tumors.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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