Overview

Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
Summary
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Niacinamide
Paclitaxel
Sorafenib
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
- ALT and AST
- INR
- Serum creatinine /= 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 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