3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Stage III or Stage IV Recurrent Non-Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00077415
• Lead Sponsor: Cancer Therapeutics Research Group

Brief Summary

RATIONALE: 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 more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine as second-line therapy works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the objective response rate in patients with stage III or IV recurrent non-small cell lung cancer treated with 3-AP (Triapine®) and gemcitabine as second-line therapy.

Secondary

* Determine the response duration, median time to progression, and overall survival of patients treated with this regimen.

* Determine the toxicity of this regimen in these patients.

* Determine the effect of 3-AP (Triapine®) on gemcitabine pharmacokinetics and cellular uptake into peripheral mononuclear cells in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to participating center.

Patients receive 3-AP (Triapine®) IV over 4 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.

NOTE: \*For course 1 only, gemcitabine is administered alone on day 1 and in combination with 3-AP (Triapine®) on days 8 and 15.

Patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 15-31 patients will be accrued for this study within 7.5-21 months.

Study Timeline

• Study First Submitted: 2004-02-10
• Study First Submitted QC: 2004-02-11
• Study First Posted: 2004-02-12
• Study Start: 2004-04
• Status Verified: 2006-08
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective tumor response as assessed by RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Duration of overall response
Pharmacokinetics
Toxicity as assessed by NCI CTCAE v3.0
Overall survival
Median time to progression

Trial Locations

Locations (8)

National University of Singapore; 🇸🇬 Singapore, Singapore

National Cancer Centre - Singapore; 🇸🇬 Singapore, Singapore

Cancer Institute at National University Hospital; 🇸🇬 Singapore, Singapore

Yonsei Cancer Center at Yonsei University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Sydney Cancer Centre at Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

Sir Charles Gairdner Hospital - Perth; 🇦🇺 Perth, Western Australia, Australia

Johns Hopkins Singapore International Medical Centre; 🇸🇬 Singapore, Singapore

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong