Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Sorafenib in Treating Patients With Recurrent or Progressive Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI	NCI-05-C-0049 6654, NCI-6654, NCI-P6272, NCT00100763

Special Category: NCI Web site featured trial

Objectives

Primary

1. Determine the response rate in patients with recurrent or progressive stage IV non-small cell lung cancer treated with sorafenib.
2. Determine the toxicity of this drug in these patients.

Secondary

1. Correlate disease response with biochemical modulation of signal transduction pathways in patients treated with this drug.
2. Determine the pharmacokinetics and pharmacogenetics of this drug in these patients.
3. Correlate changes in vascular endothelial growth factor and other angiogenic cytokines with clinical outcome in patients treated with this drug.
4. Determine time to progression and overall survival of patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer
  • Stage IV disease
• Recurrent or progressive disease
• Measurable disease
  • At least 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan
• No symptomatic brain metastases
  • Patients with previously treated brain metastases are eligible at the discretion of the principal investigator provided disease status remains stable for ≥ 3 months without steroids

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• At least 28 days since prior radiotherapy

Surgery

• At least 28 days since prior major surgery

Other

• Recovered from all prior therapy
• No prior investigational agents that target the Ras/MAPK pathway, including any of the following:
  • Antisense molecules (e.g., ISIS 2503 or ISIS 5312)
  • Farnesyl transferase inhibitors (e.g., tipifarnib or lonafarnib)
  • Anti-MEK inhibitors
• No concurrent therapeutic anticoagulants
  • Concurrent prophylactic anticoagulation (e.g., low-dose warfarin) for venous or arterial access device allowed
• No concurrent alternative or complementary therapies or over-the-counter agents unless approved by the principal investigator
• No other concurrent investigational agents
• No other concurrent anticancer therapy

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-1

  OR

• Karnofsky 70-100%

Life expectancy

• More than 3 months

Hematopoietic

• WBC > 3,000/mm³
• Absolute neutrophil count > 1,200/mm³
• Platelet count > 100,000/mm³
• No evidence of bleeding diathesis

Hepatic

• PTT ≤ 36 seconds
• INR ≤ 1.2 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST and ALT < 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

  OR

• Creatinine clearance > 45 mL/min

Cardiovascular

• No ongoing or uncontrolled symptomatic congestive heart failure
• No uncontrolled hypertension
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 2 months after study participation
• HIV negative
• No ongoing or active infection
• No other uncontrolled medical illness
• No psychiatric illness or social situation that would preclude study compliance
• No condition that would preclude swallowing tablets
• No other invasive malignancy within the past 5 years except noninvasive nonmelanoma skin cancer

Expected Enrollment

A total of 12-40 patients will be accrued for this study within 18 months.

Outcomes

Response rate
Toxicity

Correlation of disease response with biochemical modulation of signal transduction pathways in patients
Pharmacokinetics and pharmacogenetics
Correlation of changes in vascular endothelial growth factor and other angiogenic cytokines with clinical outcomes
Time to progression and overall survival

Outline

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Giuseppe Giaccone, MD, PhD, Protocol chair		Ph: 301-496-4916

Related Information

Web site for additional information
Featured trial article

Registry Information
Official Title		Phase II Study of BAY 43-9006 (Sorafenib) with Evaluation of Ras Signal Pathway in Patients with Relapsed Non-small Cell Lung Cancer
Trial Start Date		2005-03-28
Trial Completion Date		2009-05-01 (estimated)
Registered in ClinicalTrials.gov		NCT00100763
Date Submitted to PDQ		2004-12-01
Information Last Verified		2009-11-16

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