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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

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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT00801385

First Posted

December 2, 2008

Last Updated

August 21, 2009

Sponsor

Yonsei University

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

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

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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