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Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer

This study has been terminated.
( Negative sorafenib results from ESCAPE trial and safety concerns of regimen )

Sponsors and Collaborators: Hoosier Oncology Group
Bayer
ONYX Pharmaceuticals
Walther Cancer Institute
Information provided by: Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00417248
  Purpose

Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Cisplatin
Drug: Etoposide
Procedure: Radiotherapy
Drug: Sorafenib
Phase I
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Etoposide    Cisplatin    Sorafenib    Sorafenib tosylate    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Trial of Concurrent Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN06-107

Further study details as provided by Hoosier Oncology Group:

Primary Outcome Measures:
  • The primary objective is to determine the time to disease progression. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objectives include: further characterization of the safety and toxicity of this regimen as well as median overall survival. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment:   12
Study Start Date:   June 2007
Study Completion Date:   April 2008
Primary Completion Date:   April 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Cisplatin/Etoposide/Radiotherapy Followed By Sorafenib in Patients With Inoperable Stage III Non-Small Cell Lung Cancer
Drug: Cisplatin
Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
Drug: Etoposide
Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
Procedure: Radiotherapy
Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
Drug: Sorafenib
Maintenance therapy of Sorafenib 400 mg po bid, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months.

Detailed Description:

OUTLINE: This is a multi-center study.

CHEMOTHERAPY/RADIATION THERAPY (2 cycles)

  • Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle
  • Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle
  • Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) with

Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year.

Patients with progressive disease will discontinue treatment.

ECOG performance status 0 or 1

Hematopoietic:

  • Absolute neutrophil count (ANC) ≥ 1500 mm3
  • Platelet count ≥ 100,000 mm3
  • Hemoglobin ≥ 9 g/dL
  • PT or INR < 1.5 x ULN unless on anti-coagulant therapy
  • PTT < 1.5 x ULN unless on anti-coagulant therapy

Hepatic:

  • Bilirubin ≤ 1.5 x ULN
  • ALT ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
  • AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)

Renal:

  • Creatinine < 1.5 X upper limit of normal (ULN)

Cardiovascular:

  • No significant history of cardiac disease: Congestive heart failure > class II NYHA.
  • Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within 90 days prior to registration for initial therapy) or myocardial infarction within 6 months prior to registration for initial therapy.

Respiratory:

  • FEV1 ≥ 1 liter by spirometry within 60 days prior to registration for initial therapy.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Histological or cytological proof of Non Small Cell Lung Cancer (NSCLC).
  • Measurable or non-measurable disease per RECIST.
  • Unresectable Stage IIIA or IIIB disease as evaluated by imaging.
  • Must be age ≥ 18 years at the time of consent.
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Females of childbearing potential and males must be willing to use an effective method of contraception.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for initial therapy.

Exclusion Criteria:

  • No prior chemotherapy or radiotherapy for lung cancer.
  • No positive supraclavicular or scalene lymph nodes extending up into the cervical region.
  • No superior sulcus (Pancoast tumors.
  • No malignant pleural effusions. The only exception is a patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR deemed too small to tap.
  • No clinically significant or malignant pericardial effusions.
  • No CNS metastases.
  • No unintended weight loss (> 5% body weight) in the preceding 90 days prior to registration for initial therapy.
  • No treatment with any investigational agent within 30 days prior to being registered for initial therapy.
  • No prior therapy with a Ras pathway inhibitor or anti-angiogenic agent.
  • No other active cancers.
  • Females must not be breastfeeding.
  • No active clinically serious infections as judged by the treating investigator (> CTC v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • No major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for initial therapy.
  • No anticipation of need for major surgical procedure during the course of the study.
  • No minor surgical procedures such as fine needle aspirations or cone biopsies within 7 days prior to registration for initial therapy.
  • No history of allergic reactions to drugs utilizing the vehicle polysorbate 80 + polyethylene glycol (etoposide).
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for initial therapy.
  • No use inhibitors or inducers of the cytochrome p450 system CYP3A4 enzyme or other medications such as aprepitant, ketoconazole, itraconazole, quinidine, digoxin, cyclosporine, ritonavir, grapefruit products, St. John's Wort, rifampin (rifampicin), carbamazepine, phenytoin, dexamethasone, and phenobarbital.
  • No evidence or history of bleeding diathesis or coagulopathy.
  • No serious non-healing wound, ulcer, or bone fracture.
  • No known or suspected allergy to sorafenib.
  • No uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • No thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within 6 months prior to registration for initial therapy.
  • No pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks prior to registration for initial therapy.
  • No hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to registration for initial therapy.
  • No condition that impairs patient's ability to swallow whole pills or any malabsorption problem.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417248

Locations
United States, Illinois
Medical & Surgical Specialists, LLC    
      Galesburg, Illinois, United States, 61401
United States, Indiana
Indiana University Cancer Center    
      Indianapolis, Indiana, United States, 46202
Medical Consultants, P.C.    
      Muncie, Indiana, United States, 47303
Center for Cancer Care at Goshen Health System    
      Goshen, Indiana, United States, 46527
Fort Wayne Oncology & Hematology, Inc    
      Fort Wayne, Indiana, United States, 46815
Horizon Oncology Center    
      Lafayette, Indiana, United States, 47905
Northern Indiana Cancer Research Consortium    
      South Bend, Indiana, United States, 46601
United States, Ohio
Oncology Partners Network    
      Cincinnati, Ohio, United States, 45247

Sponsors and Collaborators
Hoosier Oncology Group
Bayer
ONYX Pharmaceuticals
Walther Cancer Institute

Investigators
Study Chair:     Nasser Hanna, M.D.     Hoosier Oncology Group, LLC    
  More Information


Hoosier Oncology Group Home Page  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Hoosier Oncology Group ( Nasser Hanna, M.D. )
Study ID Numbers:   HOG LUN06-107
First Received:   December 28, 2006
Last Updated:   October 20, 2008
ClinicalTrials.gov Identifier:   NCT00417248
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Etoposide phosphate
Etoposide
Sorafenib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 22, 2008




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