Clinical trial NCT00087048 (phase 2, status: terminated)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: topotecan hydrochloride
SMILES: CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed small cell lung cancer (SCLC)

               -  Recurrent extensive stage disease

               -  No mixed histology

          -  Measurable disease

               -  At least 1 bidimensionally measurable, non-central nervous system (CNS),
                  indicator lesion confirmed by CT scan or MRI

          -  Sensitive disease

               -  Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90
                  days after initiation of first-line therapy)

          -  Eligible for high-dose chemotherapy

          -  No symptomatic brain metastases affecting performance status

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

        Life expectancy

          -  At least 2 months

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9.0 g/dL

          -  Hematocrit > 35% (without transfusion)

        Hepatic

          -  Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
             transaminase (SGPT) ≤ 2 times normal*

          -  Alkaline phosphatase ≤ 2 times normal*

          -  Bilirubin ≤ 2.0 mg/dL

          -  Albumin > 2.5 g/dL

          -  Hepatitis B surface antigen negative

          -  No significant hepatic disease Note: *≤ 5 times upper limit of normal if liver
             metastases are present

        Renal

          -  Creatinine clearance ≥ 40 mL/min

        Cardiovascular

          -  No history of cardiac arrhythmias

          -  No congestive heart failure

          -  No ischemic heart disease

          -  No stroke or other embolic disease requiring daily treatment that would preclude study
             participation

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

          -  HIV negative

          -  No known seizure disorder

          -  No active infection requiring systemic therapy within the past 2 weeks

          -  No known hypersensitivity to topotecan hydrochloride

          -  No medical or psychiatric condition that would preclude study participation

          -  No other malignancy except adequately treated basal cell or squamous cell skin cancer,
             carcinoma in situ of the cervix, or stage A low-grade prostate cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

          -  More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy

          -  No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC

          -  No prior topotecan hydrochloride

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  More than 2 months since prior investigational agent

          -  No other concurrent investigational agent