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

Primary Purpose

Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib tosylate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria: Stage IIIB with pleural effusion Stage IV Measurable disease At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan The following are not considered measurable disease: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions No known brain metastases, even if treated and stable Performance status - ECOG 0-2 At least 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL No bleeding diathesis Bilirubin ≤ 2 times upper limit of normal (ULN) AST ≤ 3 times ULN (5 times ULN if hepatic metastasis present) Creatinine ≤ 1.5 times ULN No uncontrolled hypertension Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV positivity HIV negative Able to swallow tablets No uncontrolled infection No other severe underlying disease that would preclude study participation No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas No prior immunotherapy, biologic therapy, or gene therapy No concurrent prophylactic colony-stimulating factors At least 4 weeks since prior low-dose weekly chemotherapy as a radiosensitizer No other prior chemotherapy for NSCLC No concurrent chemotherapy See Chemotherapy At least 4 weeks since prior radiotherapy No prior radiotherapy to ≥ 30% of bone marrow No concurrent radiotherapy Concurrent palliative radiotherapy to nontarget lesions (e.g., painful pre-existing bony metastasis) allowed Prior adjuvant therapy allowed provided recurrent disease occurred > 6 months after completion of adjuvant therapy No prior systemic therapy for NSCLC, including all novel targeted agents (e.g., gefitinib or erlotinib) No concurrent therapeutic anticoagulation Prophylactic anticoagulation (e.g., low-dose warfarin) for venous and arterial devices allowed provided PT, INR, and PTT requirements are met No other concurrent anticancer agents or therapies No other concurrent investigational agents or therapies

Sites / Locations

  • North Central Cancer Treatment Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (sorafenib tosylate)

Arm Description

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

Outcomes

Primary Outcome Measures

Confirmed tumor response according to RECIST criteria
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.

Secondary Outcome Measures

Progression-free survival
The proportion of patients who are progression-free at 24-weeks will be computed and binomial confidence intervals for the true success proportion will be calculated.
Survival time
Estimated using the method of Kaplan-Meier.
Time-to-disease progression
Estimated using the method of Kaplan-Meier.

Full Information

First Posted
December 7, 2004
Last Updated
December 28, 2016
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00098540
Brief Title
Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title
Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial is studying how well sorafenib works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer treated with sorafenib. II. Determine the clinical toxic effects of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the 24-week progression-free survival rate in patients treated with this drug. II. Determine the overall survival of patients treated with this drug. III. Determine the time to disease progression in patients treated with this drug. IV. Correlate predictive disease markers (K-ras and B-raf mutations and ERK/pERK, AKT/pAKT, and VEGFR2/p-VEGFR2 expression) in these patients with the activity of this drug. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (sorafenib tosylate)
Arm Type
Experimental
Arm Description
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Other Intervention Name(s)
BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Confirmed tumor response according to RECIST criteria
Description
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
The proportion of patients who are progression-free at 24-weeks will be computed and binomial confidence intervals for the true success proportion will be calculated.
Time Frame
At 24 weeks
Title
Survival time
Description
Estimated using the method of Kaplan-Meier.
Time Frame
From registration to death due to any cause, assessed up to 5 years
Title
Time-to-disease progression
Description
Estimated using the method of Kaplan-Meier.
Time Frame
From registration to documentation of disease progression, assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria: Stage IIIB with pleural effusion Stage IV Measurable disease At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan The following are not considered measurable disease: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions No known brain metastases, even if treated and stable Performance status - ECOG 0-2 At least 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL No bleeding diathesis Bilirubin ≤ 2 times upper limit of normal (ULN) AST ≤ 3 times ULN (5 times ULN if hepatic metastasis present) Creatinine ≤ 1.5 times ULN No uncontrolled hypertension Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV positivity HIV negative Able to swallow tablets No uncontrolled infection No other severe underlying disease that would preclude study participation No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas No prior immunotherapy, biologic therapy, or gene therapy No concurrent prophylactic colony-stimulating factors At least 4 weeks since prior low-dose weekly chemotherapy as a radiosensitizer No other prior chemotherapy for NSCLC No concurrent chemotherapy See Chemotherapy At least 4 weeks since prior radiotherapy No prior radiotherapy to ≥ 30% of bone marrow No concurrent radiotherapy Concurrent palliative radiotherapy to nontarget lesions (e.g., painful pre-existing bony metastasis) allowed Prior adjuvant therapy allowed provided recurrent disease occurred > 6 months after completion of adjuvant therapy No prior systemic therapy for NSCLC, including all novel targeted agents (e.g., gefitinib or erlotinib) No concurrent therapeutic anticoagulation Prophylactic anticoagulation (e.g., low-dose warfarin) for venous and arterial devices allowed provided PT, INR, and PTT requirements are met No other concurrent anticancer agents or therapies No other concurrent investigational agents or therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Adjei
Organizational Affiliation
North Central Cancer Treatment Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Central Cancer Treatment Group
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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