Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066742
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2003-08-06
Brief Title:
Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Tirapazamine NSC-130181CisplatinEtoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 phase II trial is studying how well giving tirapazamine together with cisplatin etoposide and radiation therapy works in treating patients with limited-stage small cell lung cancer Drugs used in chemotherapy such as cisplatin and etoposide work in 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 Tirapazamine may make the tumor cells more sensitive to chemotherapy and radiation therapy Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To assess overall survival in patients with limited stage small cell lung cancer SCLC treated with induction tirapazamine combined with cisplatin etoposide and high dose thoracic radiotherapy followed by consolidative cisplatin and etoposide
II To assess time to treatment failure calculated from initiation of step 1 response confirmed plus unconfirmed complete plus partial during induction in the subset of patients with measurable disease and toxicity in this patient population treated with this regimen
III To investigate in an exploratory manner the association of baseline PAI-1 VEGF OPN and NDRG1 plasma markers with patient response and survival
OUTLINE This is a multicenter study
CHEMORADIOTHERAPY Patients receive tirapazamine IV over 1 hour on days 1 8 10 12 29 36 38 and 40 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 Beginning on day 1 of chemotherapy patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks
CONSOLIDATION CHEMOTHERAPY Within 28 days after completion of radiotherapy patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 30-85 patients will be accrued for this study within 17 months
I To assess overall survival in patients with limited stage small cell lung cancer SCLC treated with induction tirapazamine combined with cisplatin etoposide and high dose thoracic radiotherapy followed by consolidative cisplatin and etoposide
II To assess time to treatment failure calculated from initiation of step 1 response confirmed plus unconfirmed complete plus partial during induction in the subset of patients with measurable disease and toxicity in this patient population treated with this regimen
III To investigate in an exploratory manner the association of baseline PAI-1 VEGF OPN and NDRG1 plasma markers with patient response and survival
OUTLINE This is a multicenter study
CHEMORADIOTHERAPY Patients receive tirapazamine IV over 1 hour on days 1 8 10 12 29 36 38 and 40 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 Beginning on day 1 of chemotherapy patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks
CONSOLIDATION CHEMOTHERAPY Within 28 days after completion of radiotherapy patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 30-85 patients will be accrued for this study within 17 months
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-2012-03042 | REGISTRY | None | None |
| U10CA032102 | NIH | None | None |
| S0222 | OTHER | None | None |
| S0222 | OTHER | CTEP | httpsreporternihgovquickSearchU10CA032102 |