Clinical trial NCT00077415 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: gemcitabine hydrochloride, triapine
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, NC(=S)N\N=C\C1=C(N)C=CC=N1
Eligibility 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