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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00533585
First received: September 20, 2007
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Lung Cancer
Drug: BAY 43-9006
Drug: Paclitaxel
Drug: Carboplatin
Drug: Bevacizumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Show Detailed Description

  Eligibility

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

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. 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 Criteria:

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533585

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00533585     History of Changes
Other Study ID Numbers: 2005-0818
Study First Received: September 20, 2007
Last Updated: November 7, 2013
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
Paraplatin
Bevacizumab
Avastin
BAY 43-9006
Anti-VEGF monoclonal antibody
rhuMAb-VEGF

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pleural Effusion
Pleural Effusion, Malignant
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Pleural Neoplasms
Antibodies
Antibodies, Monoclonal
Bevacizumab
Sorafenib
Carboplatin
Paclitaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 28, 2014