Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexavar (Sorafenib, BAY43-9006) | Drug | The purpose of this study is to: 1)evaluate how your body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin, 2) measure your blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and 3) to determine the safety of sorafenib. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and pharmacokinetics of the three agents: sorafenib administered daily, without a break in dosing, in combination with carboplatin and paclitaxel, administered every 3 weeks | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety profile and pharmacokinetics of oral sorafenib daily in combination with every 3-weekly carboplatin and paclitaxel. | 2 years |
Not provided
Inclusion Criteria:
Age > or equal to 18 years
Histological or cytological documentation of cancer, except non small cell lung cancer
ECOG Performance Status of 0 or 1
Life expectancy of at least 12 weeks
No more than two prior chemotherapy regimens
Adequate bone marrow, liver and renal function as assessed by the following:
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 day period after last study drug dosing. The investigator should advise the patient regarding adequate means of contraception.
Serum creatinine < or equal to 1.5 x upper limit of normal
Ability to understand and willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures
Exclusion Criteria:
Clinically evident congestive heart failure > NYHA Class 2 (See Appendix 10.4)
Serious cardiac arrhythmias (for example requiring anti-arrhythmics)
Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
Active clinically serious infections (> Grade 2 NCI-CTC)
Patients with history of brain metastases are eligible as long as the metastasis has been treated with either stereotactic or whole brain radiation, stereotactic gamma-knife radiosurgery or neurosurgery, patient does not require ongoing treatment with dexamethasone, the patient is not on anticoagulant therapy and whose radiographic imaging is stable ≥ 4 weeks from start of treatment. Time from brain metastasis treatment to first study treatment must meet the following criteria:
History of organ allograft
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 > or equal to Grade 2
Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to Screening
Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first study treatment
Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first study treatment
Evidence or history of bleeding diathesis or coagulopathy
Serious, non-healing wound, ulcer, or bone fracture
Patients undergoing renal dialysis
Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment
Previous cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 3 years prior to first study treatment
Non small cell lung cancer
Ongoing substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Pregnant or breast-feeding patients.
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Any condition that impairs patient's ability to swallow whole pills
Any malabsorption condition
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven | Connecticut | 06511-5991 | United States | |||
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| San Antonio |
| Texas |
| 78229-3307 |
| United States |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |