Working... Menu

BAY 43-9006 in Previously Untreated Patients With Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00533585
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : February 10, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this study is to find the highest tolerable dose of BAY 43-9006 (sorafenib) and bevacizumab that can be given with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC). The safety and effectiveness of this drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: BAY 43-9006 Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab Phase 1

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : May 2006
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: BAY 43-9006 + Bevacizumab
BAY 43-9006 (Sorafenib) + Bevacizumab + Paclitaxel + Carboplatin
Drug: BAY 43-9006
Starting Dose of 200 mg orally twice a day on Day 3 through Day 19 of Cycle 1 and Days 2 through 19 of Cycle 2 and remaining cycles. Cycle is 21 days.
Other Name: Sorafenib

Drug: Paclitaxel
200 mg/m^2 By Vein Over 3 Hours on Day 1.
Other Name: Taxol

Drug: Carboplatin
Area under curve (AUC) 6 By Vein Over 30 Minutes on Day 1.
Other Name: Paraplatin

Drug: Bevacizumab
Starting Dose of 5 mg/kg By Vein Over 90 minutes on Day 1.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of BAY 43-9006 (sorafenib) and Bevacizumab in Combination with Carboplatin and Paclitaxel [ Time Frame: First day of every 21 day cycle ]
    If a dose limiting toxicity (DLT) occurs in ≥ 2 out of 6 patients at dose levels 2 - 6, dose escalation will be stopped and that dose will be declared the toxic dose. The dose level below will be declared the maximum tolerated dose if at this dose level 6 patients can be treated such that no more than 1 patient experiences a DLT.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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. Eastern Cooperative Oncology (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), international normalized ratio (INR) </= 1.5 and activated partial thromboplastin time (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 Criteria:

  1. Patients with squamous histology.
  2. Cardiac disease: Congestive heart failure (CHF) > Class II New York Heart Association (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00533585

Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Layout table for investigator information
Principal Investigator: George Blumenschein, MD M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00533585     History of Changes
Other Study ID Numbers: 2005-0818
NCI-2012-01647 ( Registry Identifier: NCI CTRP )
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
Lung Cancer
malignant pleural effusions
BAY 43-9006
Anti-VEGF monoclonal antibody

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pleural Effusion
Pleural Effusion, Malignant
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pleural Diseases
Pleural Neoplasms
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents