Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006487
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2000-11-06
Brief Title:
S0004 Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase I Study Of TirapazamineCisplatinEtoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of tirapazamine cisplatin and etoposide concurrently with radiotherapy in patients with limited stage small cell lung cancer
Determine the toxicities of this treatment regimen in these patients
Determine the response rate in these patients treated with this regimen
OUTLINE Patients are assigned to one of two induction therapy arms
Arm I Patients receive induction chemotherapy consisting of low-dose tirapazamine IV over 1 hour and cisplatin 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 also undergo radiotherapy concurrently with chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1
Arm II Patients receive induction chemotherapy consisting of high-dose tirapazamine cisplatin etoposide and radiotherapy as in arm I
Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14
Patients are followed every 2 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 50 patients 25 per arm will be accrued for this study
Determine the feasibility of tirapazamine cisplatin and etoposide concurrently with radiotherapy in patients with limited stage small cell lung cancer
Determine the toxicities of this treatment regimen in these patients
Determine the response rate in these patients treated with this regimen
OUTLINE Patients are assigned to one of two induction therapy arms
Arm I Patients receive induction chemotherapy consisting of low-dose tirapazamine IV over 1 hour and cisplatin 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 also undergo radiotherapy concurrently with chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1
Arm II Patients receive induction chemotherapy consisting of high-dose tirapazamine cisplatin etoposide and radiotherapy as in arm I
Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14
Patients are followed every 2 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 50 patients 25 per arm will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0004 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |