Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098254
Status:
COMPLETED
Last Update Posted:
2012-05-02
First Post:
2004-12-03
Brief Title:
BAY 43-9006 Sorafenib to Treat Relapsed Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the effects and side effects of BAY 43-9006 in patients with advanced recurrent or refractory non-small cell lung cancer NSCLC BAY 43-9006 is one of a new class of anticancer agents known as bi-aryl ureas
Patients 18 years of age and older with NSCLC that has recurred or progressed after one regimen of chemotherapy may be eligible for this study Candidates are screened with a medical history and physical examination blood tests tumor biopsy see below chest x-ray electrocardiogram and imaging studies including positron emission tomography-computed tomography PET-CT see below and dynamic contrast-enhanced MRI DCE-MRI see below
Participants take BAY 43-9006 by mouth twice a day morning and evening On the first and 15th days of treatment patients are admitted to the hospital for pharmacokinetic studies that is a test of how the body handles the drug For the test blood is collected at intervals at 15 minutes 30 minutes and 1 2 4 6 8 12 and 24 hours after ingestion to determine the drugs level in the bloodstream Treatment with BAY 43-9006 continues until the study doctor determines that the medication is not beneficial or the patient wishes to withdraw from the study
In addition to drug therapy patients undergo the following tests and procedures
Physical examination every 4 weeks
Blood pressure checks once a week during the first 4 weeks
Blood tests every week
CT scans or other imaging tests such as ultrasound or MRI every 8 weeks to evaluate the tumors response to treatment CT is an x-ray test that provides detailed pictures of the inside of the body It can be done from different angles providing a 3-dimensional picture of the part of the body being studied and allowing the doctor to see the location nature and extent of disease MRI uses a powerful magnet and radio waves instead of x-rays to produce accurate detailed pictures of organs and tissues
PET-CT approximately every 8 weeks to look at how different parts of the body take up and use glucose a sugar nutrient Because rapidly growing cells such as tumors use more sugar than normal cells do this test can be used to detect cancer For the test the patient is given an injection of a sugar solution in which a radioactive tracer has been attached to the sugar molecule A special camera detects the radiation emitted by the solution and the resulting images show how much sugar is being used in various parts of the body PET-CT uses the PET scan in combination with standard CT in a machine that does both tests
DCE-MRI after 2 weeks of treatment This test uses MRI with a special non-radioactive dye to examine blood flow in a certain part of the body
Tumor biopsy optional after 2 weeks of treatment A biopsy is the surgical removal of a small piece of tissue The tumor biopsy is done either using a small bore needle under CT guidance or by direct visualization using a laparoscopethoracoscope For the needle biopsy a needle is inserted through the skin and guided by CT into the tumor mass For the laparoscopythoracoscopy the patient is sedated or asleep and small lighted tubes are inserted into small holes made in the skin The tumor is located and tissue withdrawn
Patients 18 years of age and older with NSCLC that has recurred or progressed after one regimen of chemotherapy may be eligible for this study Candidates are screened with a medical history and physical examination blood tests tumor biopsy see below chest x-ray electrocardiogram and imaging studies including positron emission tomography-computed tomography PET-CT see below and dynamic contrast-enhanced MRI DCE-MRI see below
Participants take BAY 43-9006 by mouth twice a day morning and evening On the first and 15th days of treatment patients are admitted to the hospital for pharmacokinetic studies that is a test of how the body handles the drug For the test blood is collected at intervals at 15 minutes 30 minutes and 1 2 4 6 8 12 and 24 hours after ingestion to determine the drugs level in the bloodstream Treatment with BAY 43-9006 continues until the study doctor determines that the medication is not beneficial or the patient wishes to withdraw from the study
In addition to drug therapy patients undergo the following tests and procedures
Physical examination every 4 weeks
Blood pressure checks once a week during the first 4 weeks
Blood tests every week
CT scans or other imaging tests such as ultrasound or MRI every 8 weeks to evaluate the tumors response to treatment CT is an x-ray test that provides detailed pictures of the inside of the body It can be done from different angles providing a 3-dimensional picture of the part of the body being studied and allowing the doctor to see the location nature and extent of disease MRI uses a powerful magnet and radio waves instead of x-rays to produce accurate detailed pictures of organs and tissues
PET-CT approximately every 8 weeks to look at how different parts of the body take up and use glucose a sugar nutrient Because rapidly growing cells such as tumors use more sugar than normal cells do this test can be used to detect cancer For the test the patient is given an injection of a sugar solution in which a radioactive tracer has been attached to the sugar molecule A special camera detects the radiation emitted by the solution and the resulting images show how much sugar is being used in various parts of the body PET-CT uses the PET scan in combination with standard CT in a machine that does both tests
DCE-MRI after 2 weeks of treatment This test uses MRI with a special non-radioactive dye to examine blood flow in a certain part of the body
Tumor biopsy optional after 2 weeks of treatment A biopsy is the surgical removal of a small piece of tissue The tumor biopsy is done either using a small bore needle under CT guidance or by direct visualization using a laparoscopethoracoscope For the needle biopsy a needle is inserted through the skin and guided by CT into the tumor mass For the laparoscopythoracoscopy the patient is sedated or asleep and small lighted tubes are inserted into small holes made in the skin The tumor is located and tissue withdrawn
Detailed Description:
Despite advances in systemic chemotherapy patients with stage IV NSCLC will die from their disease The median survival of all patients is 8-16 months with a one year-survival rate of 33 Chemotherapy is the mainstay of treatment of advanced disease Based on available data from randomized trials current treatment recommendations are to treat with one of several effective cisplatin-doublets which have resulted in median survival of 16 to 18 months Second line chemotherapy is able to improve outcome in patients who have had prior cisplatin therapy Although these important milestones represent improvements in the care of patients with metastatic NSCLC outcome has not been able to be further improved by substituting one active drug for another in a platinum-based doublet treating patients with more than four cycles of chemotherapy or by using cisplatin-based triplets It is clear that if we are to improve outcome of NSCLC patients we will need to develop drugs with novel mechanisms of action that perhaps will inhibit major cellular signaling pathways affecting survival proliferation and angiogenesis One new compound BAY 43-9006 was designed to inhibit Raf and is also known to inhibit other kinases including VEGFR2 VEGFR3 PDGFR-beta Flt3 c-KIT and p381 BAY 43-9006 has shown in vitro activity against NSCLC cell lines NCI-H460 and A549 with tumor growth inhibition of 27 to 68 In addition BAY 43-9006 has shown activity in the H460 NSCLC xenograft model In NSCLC the proliferation signaling of the RasRafMEKERK pathway is increased due to the frequent 30 presence of K-ras mutations in the tumor Mutations in K-ras have been associated with malignant transformation of normal epithelium and constitutive activation of p21 and its downstream effects on cellular proliferation and inhibition of apoptosis Clinical observations have shown that tumors with K-ras mutations tended to be smaller but more poorly differentiated and associated with a significantly worse three-year mortality rate As mentioned above other pathways significant to the malignant potential of NSCLC particularly those involved in angiogenesis may also be affected by BAY 43-9006 The in vitro and in vivo data support the clinical investigation of BAY 43-9006 as an inhibitor of the RasRafMEKERK downstream proliferation effects The goal of this phase II trial is to determinate if BAY 43-9006 is active in NSCLC and to measure the BAY 43-9006 biological effects on the RasRafMEKERK pathway To achieve these goals patients with relapsed or recurrent NSCLC will be given BAY 43-9006 four weeks cycle of 400mg PO BID A series of correlative studies will be done during treatment to measure biological and clinical effects of BAY 43-9006 These studies will include analyses of tissue and blood samples as well as correlative imaging studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-0049 | None | None | None |