Erlotinib and Sorafenib in Chemonaive Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

NCT00722969 | Unknown Phase 2

• 2 other identifiers: 07/203EudraCT: 2007-004625-14
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

Patients with advanced or metastatic (stage IIIB-IV) non small cell lung cancer who have not received prior chemotherapy will be treated with erlotinib 150 mg once a day and sorafenib 400 mg twice a day. The objectives of the study are to assess the efficacy and safety of this combination treatment. Additional exploratory study objectives are correlation of biomarkers and imaging modalities potentially predictive for response and (progression free) survival.

Conditions

Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer; erlotinib; sorafenib

Outcome Measures

Primary Outcomes (1)

• Rate of non-progression at 6 weeks

  6 weeks

Secondary Outcomes (6)

• Best overall response rate

  end of study

• Duration of response

  End of study

• Survival

  End of study

• Toxicity

  Week 1, week 3, week 6, week 9, week 12 then every 6 weeks

• Prediction of early response and effects on tumor vascularisation by PET and perfusion CT scans

  Baseline, week 3 and week 6

Study Arms (1)

A

EXPERIMENTAL

Drug: sorafenib + erlotinib

Interventions

sorafenib + erlotinib DRUG

sorafenib 400mg b.i.d oral Erlotinib 150 mg o.i.d oral

Also known as: nexavar, tarceva

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically/cytologically advanced NSCLC stage IIIB or IV
• No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. EGFR TK inhibitors, Herceptin). Prior surgery and/or localized irradiation is permitted provided that the irradiated lesion is not the only measurable lesion.
• Age \> 18 years.
• ECOG Performance Status of 0 or 1
• Life expectancy of at least 12 weeks.
• Subjects with at least one uni-dimensional(for RECIST) measurable lesion. Lesions must be measured by CT-scan.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
• Hemoglobin \> 9.0 g/dl
• Absolute neutrophil count (ANC) \>1,500/mm3
• Platelet count \> 100,000/μl
• Total bilirubin \< 1.5 times the upper limit of normal
• ALT and AST \< 2.5 x upper limit of normal (\< 5 x upper limit of normal for patients with liver involvement of their cancer)
• Alkaline phosphatase \< 4 x ULN
• PT-INR/PTT \< 1.5 x upper limit of normal \[Patients who are being therapeutically anticoagulated with low molecular weight heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.\]
• Serum creatinine \< 1.5 x upper limit of normal.

You may not qualify if:

• Excluded medical conditions:
• History of cardiac disease: congestive heart failure \>NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension.
• History of HIV infection or chronic hepatitis B or C.
• Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
• Symptomatic metastatic brain or meningeal tumors (unless the patient is \> 1 months from definitive radiotherapy and off steroids):
• Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
• History of organ allograft.
• Patients with evidence or history of bleeding diathesis
• Patients undergoing renal dialysis
• Previous 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 \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry.
• Excluded therapies and medications, previous and concomitant:
• Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
• Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 3 weeks of start of study
• Autologous bone marrow transplant or stem cell rescue within 4 months of study
• Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. \[G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.\] \[Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study\]

Sponsors & Collaborators

• Free University Medical Center: lead

Study Sites (4)

VU university medical center

Amsterdam, 1007 MB, Netherlands

Location

Netherlands Cancer Institute

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

University Hospital Maastricht

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Sorafenib; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Egbert F Smit, Phd, MD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: April 1, 2009
• Last Updated: March 3, 2009

Record last verified: 2009-03

Locations

NL (4)