Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004202
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2000-01-21
Brief Title:
Combination Chemotherapy Radiation Therapy and RSR13 in Treating Patients With Stage III Non-small Cell Lung Cancer
Sponsor:
Spectrum Pharmaceuticals Inc
Organization:
Spectrum Pharmaceuticals Inc
Study Overview
Official Title:
A Phase II Study of Induction Chemotherapy With Paclitaxel and Carboplatin Followed by Radiation Therapy With RSR13 for Locally Advanced Inoperable Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2021-08
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:
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 Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy radiation therapy and RSR13 in treating patients who have stage III non-small cell lung cancer that cannot be removed by surgery
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy radiation therapy and RSR13 in treating patients who have stage III non-small cell lung cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES I Determine the one year survival rate two year survival rate and median survival rate in patients with locally advanced unresectable non-small cell lung cancer treated with paclitaxel and carboplatin followed by radiotherapy plus RSR13 II Determine the complete and partial response rates and progression free interval in the chest radiation portal of these patients on this regimen III Determine the time to disease progression outside of the radiation portal in these patients on this regimen IV Determine the toxic effects and adverse events associated with this regimen in these patients
OUTLINE This is a multicenter study Induction chemotherapy Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses Radiotherapy Beginning 3 to 4 weeks after induction chemotherapy patients receive RSR13 IV over 30 minutes followed by fractionated radiotherapy 5 times weekly for 6-7 weeks Patients are followed monthly for 2 months and then every 3 months thereafter until disease progression or death
PROJECTED ACCRUAL A total of 46-48 patients will be accrued for this study
OUTLINE This is a multicenter study Induction chemotherapy Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses Radiotherapy Beginning 3 to 4 weeks after induction chemotherapy patients receive RSR13 IV over 30 minutes followed by fractionated radiotherapy 5 times weekly for 6-7 weeks Patients are followed monthly for 2 months and then every 3 months thereafter until disease progression or death
PROJECTED ACCRUAL A total of 46-48 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 |
|---|---|---|---|
| VU-VCC-THO-9828 | None | None | None |
| ALLOS-RSR13RT-010 | None | None | None |