Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077350
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2004-02-10
Brief Title:
A Phase II Trial of Triapine NSC 663249 in Combination With Gemcitabine as Second Line Treatment of Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Triapine NSC 663249 in Combination With Gemcitabine as Second Line Treatment of Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Drugs used in chemotherapy such as 3-AP and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Giving 3-AP together with gemcitabine may kill more tumor cells This phase II trial is studying how well giving 3-AP together with gemcitabine works as second-line therapy in treating patients with progressive or recurrent non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the antitumor response rate by tumor measurement per the RECIST criteria in patients taking this combination in the setting of second line treatment for NSCLC
SECONDARY OBJECTIVES
I To evaluate the rate of stable disease time to treatment progression duration of response and survival of patients taking this combination treatment
II To estimate the safety and tolerability of this combination in this phase II trial of patients with relapsed NSCLC
TERTIARY OBJECTIVES
I To evaluate the potential effects of MDR polymorphisms in patients taking Triapine in this combination
II To evaluate the effect of Triapine and gemcitabine on RRM1 RRM2 and p53R2 protein expression per IHC and gene expression per RT-PCR from baseline diagnostic paraffin embedded blocks
III To evaluate both germline peripheral blood and tumor DNA for the presence of p53 mutations
OUTLINE This is a multicenter study
Patients receive 3-AP Triapine IV over 2 hours and gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for up to 15 years
I To evaluate the antitumor response rate by tumor measurement per the RECIST criteria in patients taking this combination in the setting of second line treatment for NSCLC
SECONDARY OBJECTIVES
I To evaluate the rate of stable disease time to treatment progression duration of response and survival of patients taking this combination treatment
II To estimate the safety and tolerability of this combination in this phase II trial of patients with relapsed NSCLC
TERTIARY OBJECTIVES
I To evaluate the potential effects of MDR polymorphisms in patients taking Triapine in this combination
II To evaluate the effect of Triapine and gemcitabine on RRM1 RRM2 and p53R2 protein expression per IHC and gene expression per RT-PCR from baseline diagnostic paraffin embedded blocks
III To evaluate both germline peripheral blood and tumor DNA for the presence of p53 mutations
OUTLINE This is a multicenter study
Patients receive 3-AP Triapine IV over 2 hours and gemcitabine IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for up to 15 years
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 |
|---|---|---|---|
| CDR0000350200 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |
| E1503 | None | None | None |