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Completed

NCT Number: NCT01069328

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

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

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rochester, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nexavar (Sorafenib, BAY43-9006)

Drug

Sorafenib 200 mg orally BID interrupted dosing

Bevacizumab

Drug

Bevacizumab 2.5 mg/kg intravenously

paclitaxel

Drug

Paclitaxel 200 mg/m² intravenously

carboplatin

Drug

Carboplatin AUC 6 intravenously

Primary outcomes

  1. 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

    Time frame: 2 years

Secondary outcomes

  1. 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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2010
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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