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)
Sponsor:
Collaborators:
Bayer
Onyx Pharmaceuticals
Walther Cancer Institute
Information provided by:
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00417248
First received: December 28, 2006
Last updated: April 28, 2011
Last verified: April 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

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
Experimental: 1
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 the following:

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 mm Hg or diastolic pressure > 90 mm Hg, 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
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: NCT00417248

Locations
United States, Illinois
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
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 Cancer Research Network
Bayer
Onyx Pharmaceuticals
Walther Cancer Institute
Investigators
Study Chair: Nasser Hanna, M.D. Hoosier Oncology Group, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Nasser Hanna, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00417248     History of Changes
Other Study ID Numbers: HOG LUN06-107
Study First Received: December 28, 2006
Last Updated: April 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Etoposide
Etoposide phosphate
Sorafenib
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014