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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00077415
Enrollment
31
Registered
2004-02-12
Start date
2004-04-30
Completion date
2008-02-29
Last updated
2013-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

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

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.

Interventions

DRUGgemcitabine hydrochloride
DRUGtriapine

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Cancer Therapeutics Research Group
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Objective tumor response as assessed by RECIST criteria

Secondary

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

Countries

Australia, Hong Kong, Singapore, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026