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

NCT00533585 | Completed Phase 1

• 2 other identifiers: 2005-0818NCI-2012-01647
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Lung Cancer; NSCLC; malignant pleural effusions; Sorafenib; Paclitaxel; Taxol; Carboplatin; Paraplatin; Bevacizumab; Avastin; BAY 43-9006; Anti-VEGF monoclonal antibody; rhuMAb-VEGF

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of BAY 43-9006 (sorafenib) and Bevacizumab in Combination with Carboplatin and Paclitaxel

  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.

  First day of every 21 day cycle

Study Arms (1)

BAY 43-9006 + Bevacizumab

EXPERIMENTAL

BAY 43-9006 (Sorafenib) + Bevacizumab + Paclitaxel + Carboplatin

Drug: BAY 43-9006; Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab

Interventions

BAY 43-9006 DRUG

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.

Also known as: Sorafenib

BAY 43-9006 + Bevacizumab

Paclitaxel DRUG

200 mg/m\^2 By Vein Over 3 Hours on Day 1.

Also known as: Taxol

BAY 43-9006 + Bevacizumab

Carboplatin DRUG

Area under curve (AUC) 6 By Vein Over 30 Minutes on Day 1.

Also known as: Paraplatin

BAY 43-9006 + Bevacizumab

Bevacizumab DRUG

Starting Dose of 5 mg/kg By Vein Over 90 minutes on Day 1.

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

BAY 43-9006 + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 measurable lesion. Lesions must be evaluated by computed tomography (CT) scan or magnetic resonance imagining (MRI)
• Eastern Cooperative Oncology (ECOG) Performance Status of 0 - 1
• Controlled blood pressure (defined as systolic BP \</= 150mmHg and diastolic \</= 90 mmHg)
• 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.
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment.
• 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.

You may not qualify if:

• Patients with squamous histology.
• 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)
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management
• Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C
• Active clinically serious infections (\> Grade 2 NCI-CTC Version 3.0)
• Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
• Thrombotic or embolic events such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis or pulmonary embolism
• Organ allograft
• Evidence or history of bleeding diathesis or coagulopathy
• History of/or current evidence of hemoptysis (bright red blood of 1/2 teaspoon or more)
• Peripheral neuropathy \>/= Grade 2
• 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)
• 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.
• No major surgery, open biopsy or significant traumatic injury within 4 weeks of start of first dose
• Serious, non-healing wound, ulcer, or bone fracture

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bayer: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant

Interventions

Sorafenib; Paclitaxel; Carboplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Pleural Effusion; Pleural Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• George Blumenschein, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Study Start: May 1, 2006
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

US (1)