Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499109
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2007-07-10
Brief Title:
Phase III of RRM1 ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Randomized Phase III Multicenter Trial of RRM1 ERCC1 Directed Customized Chemotherapy Versus Standard of Care for 1st Line Treatment of Patients With Advanced Non-Small-Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-06
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 is a clinical research study to evaluate if chemotherapy in the experimental arm E results in a better outcome compared to patients in the standard of care arm C
21 randomization to experimental arm E or standard arm C In arm E treatment of dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein level In arm C treatment of dual-agent chemotherapy will be gemcitabinecarboplatin ie standard of care
21 randomization to experimental arm E or standard arm C In arm E treatment of dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein level In arm C treatment of dual-agent chemotherapy will be gemcitabinecarboplatin ie standard of care
Detailed Description:
Before each cycle blood tests vital signs interim medical history and a physical exam will be performed Patients will be carefully checked so that immediate intervention can be initiated should an adverse event ie hypersensitivity occur
The last treatment cycle according to the study will be cycle 6 or any earlier cycle Certain tests will be done within 28 days after the last drug infusion These include physical exam vital signs temperature weight adverse event evaluation imaging studies and blood work
The study doctor will see the participants every 6 to 8 weeks for at least 12 months after they start treatment After that the participants will be followed every 3 months for an additional 24 months
The last treatment cycle according to the study will be cycle 6 or any earlier cycle Certain tests will be done within 28 days after the last drug infusion These include physical exam vital signs temperature weight adverse event evaluation imaging studies and blood work
The study doctor will see the participants every 6 to 8 weeks for at least 12 months after they start treatment After that the participants will be followed every 3 months for an additional 24 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 |
|---|---|---|---|
| CA129343 | OTHER_GRANT | NCI | None |
| 105372 | OTHER | None | None |
| IST 12223 | OTHER | None | None |