Trial Condition(s):
Dose escalating study with BAY43-9006 with carboplatin, paclitaxel and bevacizumab in untreated stage IIIb non-small cell lung cancer (NSCLC)
11956
Not Available
Not Available
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
- Patients must have Stage IIIB (with malignant pleural effusions) or Stage IV histological or cytological confirmation of non-small cell carcinoma (excluding squamous) - Age >/= 18 years old - Patients must have at least 1 evaluable lesion. Lesions must be evaluated by CT scan or MRI - ECOG Performance Status of 0 to 1 - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose: -- Hemoglobin >/= 9.0 g/dL -- White blood cell (WBC) count >/= 2,500/mm3 -- Absolute neutrophil count (ANC) >/= 1,500/mm3 -- Platelet count >/= 100,000/mm3 -- Total bilirubin </= 1.5 times the upper limit of normal (ULN) -- ALT and AST </= 2.5 X ULN (</= 5 X ULN for patients with liver involvement) -- INR </= 1.5 and aPTT within normal limits -- Serum creatinine </= ULN or creatinine clearance (CrCl) >/= 45 mL/min (CrCl = Wt (kg) x (140-age)/72 x Cr level, female x 0.85) for patients with creatinine levels above institutional normal -- Urinalysis (UA) must show less than 1+ protein in urine, or the patient will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein </= 1000 mg/24 hour to be eligible
- Patients with squamous histology - Cardiac disease: Congestive heart failure > Class II NYHA; active coronary artery disease (MI more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) - Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management - HIV infection or chronic hepatitis B or C - Active clinically serious infections (> Grade 2 NCI-CTC Version 3.0) - Evidence or history of CNS disease, including primary brain tumors, seizures disorders, or any brain metastasis
Locations | Status | |
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Locations M. D. Anderson Cancer Center - University of Texas Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Clinic - Rochester Rochester, United States, 55905 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Study of BAY43-9006 (sorafenib) in combination with carboplatin, paclitaxel and bevacizumab in previously untreated patients with Stage IIIB (with malignant pleural effusions) or Stage IV non-small cell lung cancer (NSCLC)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
6