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
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- 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
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 50 mL/min
Cardiovascular
- 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
Pulmonary
- No uncontrolled symptomatic pulmonary disease
- No pulmonary disease that requires oxygen therapy
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered
Endocrine therapy
- Not specified
Radiotherapy
- More than 4 weeks since prior radiotherapy and recovered
Surgery
- Not specified
Other
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective tumor response as assessed by RECIST criteria
Safety Issue:
No
Principal Investigator
Brigette Ma, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Prince of Wales Hospital
Authority:
United States: Federal Government
Study ID:
CTRG-LUN012
NCT ID:
NCT00077415
Start Date:
April 2004
Completion Date:
February 2008
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- adenocarcinoma of the lung
- bronchoalveolar cell lung cancer
- large cell lung cancer
- squamous cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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