Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-27 @ 7:56 AM
Study NCT ID:
NCT00077350
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2004-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 1.5 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 1.5 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| E1503 | None | None | View | |
| U10CA021115 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000350200 | REGISTRY | PDQ (Physician Data Query) | View |