Sorafenib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Chemotherapy
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
erlotinib hydrochloride
sorafenib tosylate
DNA analysis
mutation analysis
polymerase chain reaction
protein analysis
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
- Advanced (stage IIIB-IV) or recurrent disease
- Must have failed 1 or 2 prior chemotherapy regimens, including platinum-containing regimen
At least 1 unidimensionally measurable lesion > 10 mm by spiral CT scan or > 20 mm by conventional CT scan
- Previously irradiated lesions cannot be included as sites of measurable disease unless clear tumor progression has been documented in the lesions since the end of radiotherapy
No known or suspected brain metastases
- Patients with clinical signs or symptoms that are suspicious of brain metastasis must have a pre-treatment CT scan or MRI of the brain
- Patients with prior brain metastases are eligible provided they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- WBC 4,000-12,000/μL
- Neutrophil ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.0 times ULN
- Alkaline phosphatase ≤ 2.0 times ULN
- Serum creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- No active clinically serious infections
- No prior or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1), or any cancer curatively treated > 5 years before study
- Able to swallow oral medications
- No substance abuse or medical, psychological, or social conditions that may interfere with participation in the study or evaluation of the study results
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- No prior anti-EGFR targeted therapy
- At least 4 weeks since prior surgery
At least 4 weeks since prior and no concurrent radiotherapy
- No prior radiotherapy to the whole pelvis or chest or to ≥ 25% of the bone marrow
- No other concurrent anticancer agents (e.g., chemotherapy or immunotherapy agents) which might affect evaluation of study treatment
Sites / Locations
- Yonsei Cancer Center at Yonsei University Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Tumor response based on RECIST criteria
Secondary Outcome Measures
Response duration in patients with confirmed objective response
Disease control rate
Overall survival
Progression-free survival
Biomarker analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00801385
Brief Title
Sorafenib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Chemotherapy
Official Title
A Multicenter, Open-label, Phase II Study of Sorafenib in Combination With Erlotinib in Non-small Cell Lung Cancer (NSCLC) Refractory to One or Two Prior Chemotherapy Regimens
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to chemotherapy.
Detailed Description
OBJECTIVES:
Primary
To assess the response rate of sorafenib tosylate in combination with erlotinib hydrochloride in patients with stage IIIB-IV non-small cell lung cancer refractory to 1 or 2 prior chemotherapy regimens.
Secondary
To assess the response duration in patients treated with this regimen.
To assess the disease control rate in patients treated with this regimen.
To assess the progression-free survival of patients treated with this regimen.
To assess the overall survival of patients treated with this regimen.
To assess the safety and tolerability of this regimen in these patients.
To analyze biomarkers, including evaluation of EGFR expression, mutational analysis of EGFR and K-ras, and immunohistochemical analysis of EGFR downstream pathway (phospho-EGFR, phospho-AKT, phospho-Erk, phospho-STAT3).
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tissue samples are analyzed at the nucleic acid level for EGFR mutation (exon 18-21) and K-ras mutation (exon 2), DNA mutations via PCR, presence of EGFR protein by IHC, and downstream effectors of EGFR activation by IHC.
After completion of study therapy, patients are followed periodically.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
protein analysis
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Tumor response based on RECIST criteria
Secondary Outcome Measure Information:
Title
Response duration in patients with confirmed objective response
Title
Disease control rate
Title
Overall survival
Title
Progression-free survival
Title
Biomarker analysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Advanced (stage IIIB-IV) or recurrent disease
Must have failed 1 or 2 prior chemotherapy regimens, including platinum-containing regimen
At least 1 unidimensionally measurable lesion > 10 mm by spiral CT scan or > 20 mm by conventional CT scan
Previously irradiated lesions cannot be included as sites of measurable disease unless clear tumor progression has been documented in the lesions since the end of radiotherapy
No known or suspected brain metastases
Patients with clinical signs or symptoms that are suspicious of brain metastasis must have a pre-treatment CT scan or MRI of the brain
Patients with prior brain metastases are eligible provided they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
WBC 4,000-12,000/μL
Neutrophil ≥ 1,500/μL
Platelet count ≥ 100,000/μL
Hemoglobin ≥ 9.0 g/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 2.0 times ULN
Alkaline phosphatase ≤ 2.0 times ULN
Serum creatinine ≤ 1.5 times ULN
Not pregnant or nursing
No active clinically serious infections
No prior or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1), or any cancer curatively treated > 5 years before study
Able to swallow oral medications
No substance abuse or medical, psychological, or social conditions that may interfere with participation in the study or evaluation of the study results
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Recovered from all prior therapy
No prior anti-EGFR targeted therapy
At least 4 weeks since prior surgery
At least 4 weeks since prior and no concurrent radiotherapy
No prior radiotherapy to the whole pelvis or chest or to ≥ 25% of the bone marrow
No other concurrent anticancer agents (e.g., chemotherapy or immunotherapy agents) which might affect evaluation of study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hang Kim, MD
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei Cancer Center at Yonsei University Medical Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Hang Kim, MD
Phone
82-2-2228-8131
Email
kjhang@yuhs.ac
12. IPD Sharing Statement
Citations:
PubMed Identifier
26898607
Citation
Lim SM, Cho BC, Kim SW, Kang SY, Heo DS, Kim HT, Lee DH, Kim DW, Jung M, Choi JH, Shim HS, Choi JR, Kim JH. A multicenter phase II study of sorafenib in combination with erlotinib in patients with advanced non-small cell lung cancer (KCSG-0806). Lung Cancer. 2016 Mar;93:1-8. doi: 10.1016/j.lungcan.2015.12.005. Epub 2015 Dec 29.
Results Reference
derived
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Sorafenib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Chemotherapy
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