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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00417248
• Other study ID #: HOG LUN06-107
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: December 28, 2006
• Last updated: April 28, 2011
• Start date: June 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2011
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Cisplatin
Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
• 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

Locations

Country	Name	City	State
United States	Oncology Partners Network	Cincinnati	Ohio
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Medical & Surgical Specialists, LLC	Galesburg	Illinois
United States	Center for Cancer Care at Goshen Health System	Goshen	Indiana
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Horizon Oncology Center	Lafayette	Indiana
United States	Medical Consultants, P.C.	Muncie	Indiana
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Bayer, Onyx Pharmaceuticals, Walther Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to determine the time to disease progression		18 months	No
Secondary	The secondary objectives include: further characterization of the safety and toxicity of this regimen as well as median overall survival		18 months	Yes

External Links

•   Hoosier Oncology Group Home Page