Sorafenib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Chemotherapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Yonsei University
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00801385
First received: December 2, 2008
Last updated: August 21, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: erlotinib hydrochloride Drug: sorafenib tosylate Genetic: DNA analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: protein analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Tumor response based on RECIST criteria [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response duration in patients with confirmed objective response [ Designated as safety issue: No ]
- Disease control rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Biomarker analysis [ Designated as safety issue: No ]
| Estimated Enrollment: | 47 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801385
Locations
| Korea, Republic of | |
| Yonsei Cancer Center at Yonsei University Medical Center | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Joo-Hang Kim, MD 82-2-2228-8131 kjhang@yuhs.ac | |
Sponsors and Collaborators
Yonsei University
Investigators
| Principal Investigator: | Joo-Hang Kim, MD | Yonsei University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00801385 History of Changes |
| Other Study ID Numbers: | CDR0000618003, YONSEI-4-2008-0160 |
| Study First Received: | December 2, 2008 |
| Last Updated: | August 21, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Erlotinib Sorafenib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013