Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280787
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2006-01-19
Brief Title:
Induction Chemotherapy Using Paclitaxel Carboplatin CPT-11 With Pegfilgrastim
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
LCCC 0215 Induction Chemotherapy Using Paclitaxel Carboplatin CPT-11 With Pegfilgrastim Support Followed by Conformal Radiotherapy and PaclitaxelCarboplatinZD1839 in Locally Advanced Unresectable Stage IIIAB Non-Small Cell Carcinoma of the Lung
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Patients enrolled on this study will have been diagnosed with non-small cell lung cancer which cannot be removed by an operation The standard treatment for this disease is a combination of chemotherapy and radiation therapy however the best way to combine these treatments is not known This study will examine if the combination of chemotherapy and radiotherapy has an increased effect on slowing tumor growth with the addition of a drug called ZD1839
In this study chemotherapy will be given initially induction therapy to try to control the spread of the cancer Then radiation and chemotherapy will be given together Receiving chemotherapy at the same time as radiation treatments can enhance the effect of the radiation In this study patients will receive a drug called ZD1839 In laboratory tests on cancer cells ZD1839 has shown an additive effect when used in combination with radiation ZD1839 has also been shown to slow or stop growth in tumors
The purpose of this study is to determine the side effects and effectiveness of using ZD1839 when used with radiation in this treatment regimen induction chemotherapy followed by combination chemotherapy ZD1839 and radiation therapy
In this study chemotherapy will be given initially induction therapy to try to control the spread of the cancer Then radiation and chemotherapy will be given together Receiving chemotherapy at the same time as radiation treatments can enhance the effect of the radiation In this study patients will receive a drug called ZD1839 In laboratory tests on cancer cells ZD1839 has shown an additive effect when used in combination with radiation ZD1839 has also been shown to slow or stop growth in tumors
The purpose of this study is to determine the side effects and effectiveness of using ZD1839 when used with radiation in this treatment regimen induction chemotherapy followed by combination chemotherapy ZD1839 and radiation therapy
Detailed Description:
Lung cancer remains the leading cause of cancer-related mortality in the United States In 2002 approximately 170000 new cases of lung cancer will be diagnosed and approximately 160000 deaths will occur Eighty percent of cases of lung cancer are of the non-small cell type and 30 to 35 will be Stage IIIAB and are considered potentially curable The standard of care in the United States for those patients with unresectable Stage IIIAB and a good performance status PS is a combination of systemic chemotherapy and thoracic radiation therapy TRT What is not clear in the management of these patients is the optimal strategy to employ in the combined-modality approach as well as the optimal chemotherapy and radiation therapy dose and schedule
Induction and Concurrent Chemoradiation Therapy for Stage IIIAB NSCLC The use of combined modality has become the standard of care in unresectable Stage IIIAB non-small cell lung cancer NSCLC In the curative approach to this disease both local control and eradication of occult micrometastatic disease must be achieved Combined-modality trials employing induction chemotherapy have suggested a reduction in the rate of metastatic disease suggesting that effectively delivered chemotherapy can eradicate occult micrometastatic disease All of the trials cited have shown improved survival for the combined-modality arm Combined-modality trials employing concurrent chemoradiation have suggested improved loco-regional control resulting in improved survival These data suggest that both induction and concurrent treatment may be important and may exert their benefit in different manners induction therapy with effective chemotherapy reduces the rate of overt metastatic disease while concurrent treatment improves local control by enhancing the local effect of TRT Four trials to date have been published addressing sequential versus concurrent therapy In these trials concurrent treatment yielded improved survival over the sequential approach The value of either induction or consolidation therapy in addition to concurrent chemotherapy is currently being addressed in randomized Phase III trials
The study will evaluate the incorporation of ZD1839 with concurrent CP and TCRT to a dose of 74 Gy following 2 cycles of induction CIP The primary objective will be to define the toxicity profile of this approach With amendment 2 patients will no longer receive maintenance ZD1839 Given the data generated on LCCC 9603 and 2001 this hybrid platform of induction CIP followed by concurrent TCRT 74 Gy and CP seems appropriate for incorporation of ZD1839 because of the general tolerance of this therapy in good PS unresectable Stage III NSCLC subjects Given that esophagitis is the primary toxicity seen with this approach stopping rules will be in place for excessive esophageal toxicity
Induction and Concurrent Chemoradiation Therapy for Stage IIIAB NSCLC The use of combined modality has become the standard of care in unresectable Stage IIIAB non-small cell lung cancer NSCLC In the curative approach to this disease both local control and eradication of occult micrometastatic disease must be achieved Combined-modality trials employing induction chemotherapy have suggested a reduction in the rate of metastatic disease suggesting that effectively delivered chemotherapy can eradicate occult micrometastatic disease All of the trials cited have shown improved survival for the combined-modality arm Combined-modality trials employing concurrent chemoradiation have suggested improved loco-regional control resulting in improved survival These data suggest that both induction and concurrent treatment may be important and may exert their benefit in different manners induction therapy with effective chemotherapy reduces the rate of overt metastatic disease while concurrent treatment improves local control by enhancing the local effect of TRT Four trials to date have been published addressing sequential versus concurrent therapy In these trials concurrent treatment yielded improved survival over the sequential approach The value of either induction or consolidation therapy in addition to concurrent chemotherapy is currently being addressed in randomized Phase III trials
The study will evaluate the incorporation of ZD1839 with concurrent CP and TCRT to a dose of 74 Gy following 2 cycles of induction CIP The primary objective will be to define the toxicity profile of this approach With amendment 2 patients will no longer receive maintenance ZD1839 Given the data generated on LCCC 9603 and 2001 this hybrid platform of induction CIP followed by concurrent TCRT 74 Gy and CP seems appropriate for incorporation of ZD1839 because of the general tolerance of this therapy in good PS unresectable Stage III NSCLC subjects Given that esophagitis is the primary toxicity seen with this approach stopping rules will be in place for excessive esophageal toxicity
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