Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033410
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2002-04-09
Brief Title:
Chemotherapy Tirapazamine and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
California Cancer Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of Tirapazamine NSC 130181 Paclitaxel And Carboplatin With Concurrent Radiation Followed By TirapazaminePaclitaxelCarboplatin Consolidation For Stage III Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 Tirapazamine may make the tumor cells more sensitive to radiation therapy Combining chemotherapy radiation therapy and tirapazamine may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining chemotherapy with tirapazamine and radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of combining chemotherapy with tirapazamine and radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of tirapazamine when administered with paclitaxel carboplatin and concurrent radiotherapy in patients with stage IIB-IIIB non-small cell lung cancer
Determine preliminarily the response rate and survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of tirapazamine
Patients receive induction chemotherapy comprising tirapazamine IV over 2 hours and carboplatin IV over 30 minutes on days 1 8 15 22 29 and 36 and paclitaxel IV over 1 hour on days 1 4 8 11 15 18 22 25 29 32 36 and 39 Beginning on day 1 patients undergo radiotherapy once daily 5 days a week for 65 weeks Beginning 4-5 weeks after completion of radiotherapy patients with stable or responding disease receive consolidation chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 1 and 22
Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 3-30 patients will be accrued for this study
Determine the maximum tolerated dose of tirapazamine when administered with paclitaxel carboplatin and concurrent radiotherapy in patients with stage IIB-IIIB non-small cell lung cancer
Determine preliminarily the response rate and survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of tirapazamine
Patients receive induction chemotherapy comprising tirapazamine IV over 2 hours and carboplatin IV over 30 minutes on days 1 8 15 22 29 and 36 and paclitaxel IV over 1 hour on days 1 4 8 11 15 18 22 25 29 32 36 and 39 Beginning on day 1 patients undergo radiotherapy once daily 5 days a week for 65 weeks Beginning 4-5 weeks after completion of radiotherapy patients with stable or responding disease receive consolidation chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 1 and 22
Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 3-30 patients 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 |
|---|---|---|---|
| NCI-571 | None | None | None |
| CCC-PHI-31 | None | None | None |
| CHNMC-PHI-31 | None | None | None |