Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334815
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2006-06-07
Brief Title:
Combination Chemotherapy Radiation Therapy and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Trial of CisplatinEtoposideRadiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab NSC-704865 in Three Cohorts of Patients With Inoperable Locally Advanced Stage III Non-small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 clinical trial studies combination chemotherapy radiation therapy and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery Drugs used in chemotherapy such as cisplatin etoposide and docetaxel work in different ways to stop the growth of cancertumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Radiation therapy uses high-energy x-rays to kill tumor cells Monoclonal antibodies such as bevacizumab may interfere with the ability of tumor cells to grow and spread Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving more than one drug combination chemotherapy together with radiation therapy and bevacizumab may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the frequency and severity of toxic effects of induction therapy comprising cisplatin etoposide and radiotherapy with or without bevacizumab followed by consolidation therapy comprising docetaxel and bevacizumab in terms of grade 4 or 5 hemorrhage in patients with newly diagnosed unresectable stage III non-small cell lung cancer
SECONDARY OBJECTIVES
I Determine progression-free and overall survival of patients treated with these regimens
II Determine response confirmed unconfirmed partial and complete in patients with measurable disease treated with these regimens
OUTLINE This is a pilot multicenter study Patients are stratified according to risk high vs low
NOTE High-risk stratum closed to accrual as of 22009
INDUCTION THERAPY Patients in each stratum are assigned to 1 of 3 sequential treatment groups
GROUP 1 Patients receive cisplatin intravenously IV over 1 hour on days 1 8 29 and 36 and etoposide IV over 1 hour on days 1-5 and 29-33 Patients undergo concurrent thoracic radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-47
GROUP 2 Patients receive cisplatin etoposide and thoracic radiotherapy as in group 1 Patients also receive bevacizumab IV over 30-90 minutes on days 15 36 and 57
GROUP 3 Patients receive cisplatin etoposide and thoracic radiotherapy as in group 1 Patients also receive bevacizumab IV over 30-90 minutes on days 1 22 and 43
CONSOLIDATION CHEMOTHERAPY Beginning 3-6 weeks after completion of induction therapy all patients receive consolidation chemotherapy comprising docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 2 and continuing until blood counts recover OR pegfilgrastim SC once on day 2
Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed periodically for up to 4 years
I Determine the frequency and severity of toxic effects of induction therapy comprising cisplatin etoposide and radiotherapy with or without bevacizumab followed by consolidation therapy comprising docetaxel and bevacizumab in terms of grade 4 or 5 hemorrhage in patients with newly diagnosed unresectable stage III non-small cell lung cancer
SECONDARY OBJECTIVES
I Determine progression-free and overall survival of patients treated with these regimens
II Determine response confirmed unconfirmed partial and complete in patients with measurable disease treated with these regimens
OUTLINE This is a pilot multicenter study Patients are stratified according to risk high vs low
NOTE High-risk stratum closed to accrual as of 22009
INDUCTION THERAPY Patients in each stratum are assigned to 1 of 3 sequential treatment groups
GROUP 1 Patients receive cisplatin intravenously IV over 1 hour on days 1 8 29 and 36 and etoposide IV over 1 hour on days 1-5 and 29-33 Patients undergo concurrent thoracic radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-47
GROUP 2 Patients receive cisplatin etoposide and thoracic radiotherapy as in group 1 Patients also receive bevacizumab IV over 30-90 minutes on days 15 36 and 57
GROUP 3 Patients receive cisplatin etoposide and thoracic radiotherapy as in group 1 Patients also receive bevacizumab IV over 30-90 minutes on days 1 22 and 43
CONSOLIDATION CHEMOTHERAPY Beginning 3-6 weeks after completion of induction therapy all patients receive consolidation chemotherapy comprising docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 2 and continuing until blood counts recover OR pegfilgrastim SC once on day 2
Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity After completion of study treatment patients are followed periodically for up to 4 years
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 |
|---|---|---|---|
| NCI-2009-01097 | REGISTRY | None | None |
| SWOG-S0533 | None | None | None |
| CDR0000472907 | None | None | None |
| S0533 | OTHER | None | None |
| S0533 | OTHER | None | None |
| U10CA180888 | NIH | None | None |
| U10CA032102 | NIH | CTEP | httpsreporternihgovquickSearchU10CA032102 |