Clinical trial NCT00077350 (phase 2, status: completed)
Conditions: recurrent non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: triapine, gemcitabine hydrochloride
SMILES: NC(=S)N\N=C\C1=C(N)C=CC=N1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed non-small cell lung cancer (NSCLC);
             cytology alone is not acceptable

          -  Patients must have progressive or recurrent NSCLC, and must have failed one and only
             one prior cytotoxic chemotherapy regimen for advanced disease; patients must not have
             received prior gemcitabine chemotherapy

          -  Patients must have measurable disease, as defined by RECIST, within 4 weeks prior to
             registration

          -  Patients must have an ECOG performance status of 0 or 1

          -  Bilirubin < 1.5 x upper limit of normal

          -  AST (SGOT) < 3 x upper limit of normal

          -  Serum creatinine =< 1.5 mg/dL, or calculated creatinine clearance >= 60 mL/min

          -  Absolute granulocyte count >= 1500/mm3 and WBC >= 3000/mm^3

          -  Hemoglobin >= 9 g/L

          -  Platelet count >= 100,000/mm^3

          -  Patients must have completed any radiation therapy >= 3 weeks prior to registration

          -  Patients must have completed prior cytotoxic chemotherapy >= 3 weeks prior to
             registration and have recovered from adverse effects from the chemotherapy to =< Grade
             1, or baseline

          -  Patients with brain metastases which have been treated are eligible if the patient is
             > 3 weeks post completion of treatment for their brain metastases, and patient is
             neurologically stable; patients with previous brain metastases who have not yet
             received therapy specifically intended for their brain metastases are not eligible to
             enroll in this protocol

          -  Life expectancy greater than 3 months

          -  Pregnant women are excluded from this study because Triapine® is a heterocyclic
             carboxaldehyde thiosemicarbazone with the potential for teratogenic or abortifacient
             effects; because there is an unknown but potential risk for adverse events in nursing
             infants secondary to treatment of the mother with Triapine®, breastfeeding should be
             discontinued if the mother is treated with Triapine®; women must not be pregnant or
             breastfeeding due to the absence of information regarding the use of these agents in
             these populations; a negative serum pregnancy test is required within 14 days of study
             entry; the effects of Triapine® on the developing human fetus at the recommended
             therapeutic dose are unknown; for this reason and because heterocyclic carboxaldehyde
             thiosemicarbazones as well as other therapeutic agents used in this trial are known to
             be teratogenic, women of child-bearing potential and men must agree to use adequate
             contraception (hormonal or barrier method of birth control; abstinence) prior to study
             entry and for the duration of study participation; should a woman become pregnant or
             suspect she is pregnant while participating in this study, she should inform her
             treating physician immediately

          -  Because patients with immune deficiency are at increased risk of lethal infections
             when treated with marrow-suppressive therapy, HIV-positive patients receiving
             combination antiretroviral therapy are excluded from the study because of possible
             pharmacokinetic interactions with Triapine®

          -  Patients must not have an active second malignancy

          -  Patients must not have, at the time of registration, uncontrolled intercurrent illness
             including, but not limited to, ongoing or active infection, or psychiatric
             illness/social situations that would limit compliance with study requirements;
             furthermore, since hypoxemia may cause serious adverse events in persons with serious
             cardiac and/or pulmonary disease, patients at the time of registration with a history
             of myocardial infarction within the prior 6 months, or with symptomatic congestive
             heart failure, unstable angina pectoris, cardiac arrhythmia requiring medical
             intervention (with the exception of chronic, stable, asymptomatic atrial
             fibrillation), or pulmonary disease requiring oxygen are excluded

          -  Patients must not have dementia or active psychosis

          -  Patients must not have used any investigational agent in the month before study
             enrollment

          -  Patients must not have a history of allergic reactions attributed to compounds of
             similar chemical or biologic composition to Triapine® or other agents used in this
             study

          -  Patients must not have a clinical history of G6PD (glucose-6-phosphate dehydrogenase)
             deficiency; persons at high risk for this condition (patients of African, Asian, or
             Mediterranean origin/ancestry) must undergo specific clinical testing at protocol
             entry for this condition; patients testing positive for G6PD deficiency are excluded
             from protocol entry