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

This study is currently recruiting patients.

Sponsored by: Cancer Therapeutics Research Group
Information provided by: National Cancer Institute (NCI)

Purpose

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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of 3-AP in combination with gemcitabine as second-line therapy in treating patients who have recurrent stage III or stage IV non-small cell lung cancer.

Condition Treatment or Intervention Phase
Non-small cell lung cancer
 Drug: 3-AP
 Drug: gemcitabine
 Procedure: chemosensitization/potentiation
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lung Cancer;   Respiratory Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of 3-AP (Triapine®) and Gemcitabine as Second-Line Therapy for Patients With Stage III or IV Recurrent Non-Small Cell Lung Cancer

Further Study Details: 

OBJECTIVES: Primary

Secondary

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

Performance status

Life expectancy

Hematopoietic

Hepatic

Renal

Cardiovascular

Pulmonary

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

Surgery

Other


Location and Contact Information


Australia, New South Wales
      Sydney Cancer Centre at Royal Prince Alfred Hospital, Sydney,  New South Wales,  2050,  Australia; Recruiting
Michael Boyer  61-2-9515-5494 

Hong Kong
      Prince of Wales Hospital, Shatin, New Territories,  Hong Kong; Recruiting
Brigette Ma, MD  852-2632-2989 

Korea, Republic of
      Yonsei Cancer Center, Seoul,  120-752,  Korea, Republic of; Recruiting
Jae Kyung Roh, MD  82-2-361-7618    jkroh@yumc.yonsei.ac.kr 

Singapore
      Cancer Institute at National University Hospital, Singapore,  119074,  Singapore; Recruiting
Ross A Soo, MD  65-6772-4621    soolk@nuh.com.sg 

      Johns Hopkins - Singapore, Singapore,  119074,  Singapore; Recruiting
Alex Yuang-Chi Chang, MD  65-6777-2570    alexchang@jhnuh.com.sg 

      National Cancer Centre - Singapore, Singapore,  169610,  Singapore; Recruiting
Tan Eng Huat, MD  65-6-436-8171    dmoteh@nccs.com.sq 

      National University of Singapore, Singapore,  119260,  Singapore; Recruiting
Theresa Tan  65-6874-3685 

Study chairs or principal investigators

Brigette Ma, MD,  Study Chair,  Prince of Wales Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000350313; CTRG-LUN012; NCI-6256
Record last reviewed:  August 2004
Record first received:  February 10, 2004
ClinicalTrials.gov Identifier:  NCT00077415
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29
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