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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077415
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : May 15, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

February 10, 2004
February 12, 2004
May 15, 2013
April 2004
January 2008   (Final data collection date for primary outcome measure)
Objective tumor response as assessed by RECIST criteria
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Complete list of historical versions of study NCT00077415 on Archive Site
  • Toxicity as assessed by NCI CTCAE v3.0
  • Overall survival
  • Median time to progression
  • Duration of overall response
  • Pharmacokinetics
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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
A Randomized Phase II Study Of Triapine® Alone Versus Triapine and Gemcitabine As Second-Line Treatment Of Advanced Non-Small-Cell-Lung Cancer In Patients Who Had Prior Gemcitabine With Evaluation Of The Effect Of Triapine® On Gemcitabine Pharmacokinetics and Cellular Uptake In Peripheral Mononuclear Cells

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.



  • 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.


  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: triapine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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February 2008
January 2008   (Final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed* non-small cell lung cancer (NSCLC)

    • Stage III or IV disease
    • One of the following cellular types:

      • Adenocarcinoma
      • Non-diffuse bronchoalveolar cell carcinoma
      • Large cell carcinoma
      • Squamous cell carcinoma NOTE: *A repeat biopsy of any accessible tumor site is required if > 5 years have elapsed since the initial diagnosis
  • Progressive disease after 1 prior gemcitabine-containing chemotherapy regimen for stage III or IV NSCLC and must have achieved, at least once, a partial response, complete response, or stable disease during therapy

    • Not a primary non-responder and experienced only progressive disease during gemcitabine-containing chemotherapy
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No glucose-6-phosphate dehydrogenase (G6PD) deficiency


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)


  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 50 mL/min


  • No prior uncontrolled cardiac disease
  • No myocardial infarction within the past 12 months
  • No symptomatic congestive heart failure
  • No coronary artery disease
  • No cardiac arrhythmia


  • No uncontrolled symptomatic pulmonary disease
  • No pulmonary disease that requires oxygen therapy


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except completely treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • Not specified


  • More than 4 weeks since prior radiotherapy and recovered


  • Not specified


  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Hong Kong,   Korea, Republic of,   Singapore
CDR0000350313 ( Registry Identifier: PDQ (Physician Data Query) )
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Cancer Therapeutics Research Group
National Cancer Institute (NCI)
Study Chair: Brigette Ma, MD Prince of Wales Hospital
National Cancer Institute (NCI)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP