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BAY 43-9006 in Previously Untreated Patients With Non-Small Cell Lung Cancer (NSCLC)
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Bayer
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00533585
  Purpose

Primary Objective:

-To define the safety profile and to determine the maximum tolerated dose (MTD) of BAY 43-9006 (sorafenib) and bevacizumab in combination with carboplatin and paclitaxel.

Secondary Objective:

-To evaluate the pharmacokinetics, pharmacodynamics and tumor response of patients treated with BAY 43-9006 (sorafenib) in combination with carboplatin, paclitaxel, and bevacizumab.


Condition Intervention Phase
Lung Cancer
Drug: BAY 43-9006
Drug: Paclitaxel
Drug: Carboplatin
Drug: Bevacizumab
Phase I

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Paclitaxel Sorafenib Sorafenib tosylate Bevacizumab Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I Dose-Escalating, Open-Label, Non-Placebo Controlled Study of BAY 43-9006 (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)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To find the highest tolerable dose of BAY 43-9006 (sorafenib) and bevacizumab that can be given with paclitaxel and carboplatin in patients with NSCLC. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety and effectiveness of this drug combination will also be studied. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
BAY 43-9006 + Bevacizumab + Paclitaxel + Carboplatin
Drug: BAY 43-9006
200 mg PO Twice Daily
Drug: Paclitaxel
200 mg/m^2 IV Over 3 Hours
Drug: Carboplatin
AUC 6 IV Over 30 Minutes
Drug: Bevacizumab
5 mg/kg Over 90 minutes

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
  2. Patients must have Stage IIIB (with malignant pleural effusions) or Stage IV histological or cytological confirmation of non-small cell carcinoma (excluding squamous).
  3. Age >/= 18 years old
  4. Patients must have at least 1 measurable lesion. Lesions must be evaluated by computed tomography (CT) scan or magnetic resonance imagining (MRI)
  5. ECOG Performance Status of 0 - 1
  6. Controlled blood pressure (defined as systolic BP </= 150mmHg and diastolic </= 90 mmHg)
  7. 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.
  8. Inclusion Criteria #7: 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 urine, or the patient will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour collection will be required and must show total protein </= 1000 mg/24 hour to be eligible
  9. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment.
  10. 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 what is considered adequate contraception.

Exclusion:

  1. Patients with squamous histology.
  2. Cardiac disease: Congestive heart failure (CHF) > Class II NYHA; active coronary artery disease (myocardial infarction) [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)
  3. Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management
  4. Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C
  5. Active clinically serious infections (> Grade 2 NCI-CTC Version 3.0)
  6. History of brain metastases. Patients with history of brain metastases are eligible as long as the metastasis has been treated with either stereotactic whole brain radiation or neurosurgery, patient does not require ongoing treatment with dexamethasone and patient's radiographic imaging is stable >/= 4 weeks from start of treatment. Time from brain metastasis treatment to first study treatment must meet the following criteria: Stereotactic whole brain radiation >/= 4 weeks from first study treatment, Neurosurgery >/= 24 weeks from first study treatment, continued in exclusion # 7
  7. Continued from exclusion criterion # 6: Brain biopsy >/= 12 weeks from first study treatment.
  8. Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
  9. Thrombotic or embolic events such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis or pulmonary embolism
  10. Organ allograft
  11. Evidence or history of bleeding diathesis or coagulopathy
  12. History of/or current evidence of hemoptysis (bright red blood of 1/2 teaspoon or more)
  13. Peripheral neuropathy >/= Grade 2
  14. Anticancer chemotherapy or immunotherapy: Anticancer therapy is defined as any agent or combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints (except patients who have received adjuvant chemotherapy > 52 weeks from Cycle 1 Day 1)
  15. Radiotherapy to the target lesions within 3 weeks of start of first dose. Toxicities from radiotherapy must have resolved prior to start of first dose.
  16. No major surgery, open biopsy or significant traumatic injury within 4 weeks of start of first dose
  17. Serious, non-healing wound, ulcer, or bone fracture
  18. Granulocyte growth factors (G-CSF), within 3 weeks of study entry.
  19. Patients taking chronic erythropoietin are permitted provided no dose adjustment is made within 2 months prior to start of first dose
  20. Pregnant or breast feeding patients
  21. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  22. Known or suspected allergy to any recombinant human antibodies, or compounds of similar chemical or biologic composition to sorafenib or any of the drugs in this study
  23. Any condition that is unstable or could jeopardize the safety or compliance of the patient in the study
  24. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the study EXCEPT cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated > 3 years prior to study entry
  25. Any condition that impairs the patient's ability to swallow pills as a whole
  26. Any malabsorption conditions
  27. Therapeutic anticoagulation with warfarin, heparins, or heparinoids
  28. Patients takin phenytoin, carbamazepine, and Phenobarbital
  29. Patients taking rifampin, St. John's Wort
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533585

Contacts
Contact: George Blumenschein, MD 713-792-6363

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: George Blumenschein, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bayer
Investigators
Principal Investigator: George Blumenschein, MD U.T.M.D. Anderson Cancer Center
  More Information

MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( George Blumenschein, MD/Assistant Professor )
Study ID Numbers: 2005-0818
Study First Received: September 20, 2007
Last Updated: September 26, 2008
ClinicalTrials.gov Identifier: NCT00533585  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
Lung Cancer
NSCLC
malignant pleural effusions
Sorafenib
Paclitaxel
Taxol
Carboplatin
Bevacizumab
Avastin
BAY 43-9006

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Pleural Diseases
Pleural Effusion, Malignant
Carboplatin
Bevacizumab
Carcinoma
Antibodies, Monoclonal
Pleural Effusion
Antibodies
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Lung Diseases
Sorafenib
Carcinoma, Non-Small-Cell Lung
Immunoglobulins
Neoplasms, Glandular and Epithelial
Pleural Neoplasms

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Protein Kinase Inhibitors
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009