Clinical trial NCT01069328: Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Lung Cancer
Keywords: Lung
cancer
NSCLC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The primary objective of this study is to define the safety profile and maximum tolerated dose (MTD) of BAY43-9006 (sorafenib) administered in combination with, carboplatin, paclitaxel and bevacizumab
timeFrame: 2 years
Secondary outcomes:
measure: The secondary objectives include evaluation of pharmacokinetics, biomarkers, pharmacodynamics and tumor response of patients treated with BAY43-9006 (sorafenib) in combination with bevacizumab, paclitaxel and carboplatin
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
state: Minnesota
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: