A Phase II Trial of Triapine (NSC #663249) in Combination With Gemcitabine as Second Line Treatment of Non-Small Cell Lung Cancer

Recurrent Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrent Non-small Cell Lung Cancer

• NCT number: NCT00077350
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: July 2004