Clinical trial NCT00375193 (phase 2, status: completed)
Conditions: small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: amrubicin
SMILES: [H][C@@]1(C[C@@](N)(CC2=C1C(O)=C1C(=O)C3=CC=CC=C3C(=O)C1=C2O)C(C)=O)O[C@H]1C[C@H](O)[C@H](O)CO1
Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of SCLC; extensive-disease (ED) at time of study
             entry

          -  Refractory to first-line platinum-based chemotherapy (i.e., has received one prior
             platinum-based chemotherapy regimen) defined as one of the following:

               -  Best response to first-line chemotherapy is radiographically documented
                  progression (refractory disease)

               -  Best response to first-line chemotherapy is radiographically documented response
                  or stable disease, with subsequent documented progression during continuing
                  chemotherapy (resistant relapse)

               -  Documented progression within 90 days of completion of first-line chemotherapy
                  (last dose of chemotherapy), regardless of best response to treatment (resistant
                  relapse)

          -  At least 18 years of age

          -  ECOG Performance Status of 0, 1, or 2

          -  Measurable disease defined by RECIST criteria

               -  Measurable disease: The presence of at least one measurable lesion. If only one
                  lesion is present, the neoplastic nature of the disease site should be confirmed
                  by histology and/or cytology.

               -  Measurable lesion: Lesions that can be accurately measured in at least one
                  dimension with the longest diameter ≥20mm using conventional techniques or ≥10mm
                  using spiral CT scans.

          -  CT (including spiral CT) scans and MRI are the preferred methods of measurement;
             however, chest x-rays are acceptable if the lesions are clearly defined and surrounded
             by aerated lung. Clinically detected lesions will only be considered measurable when
             they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of
             skin lesions, documentation by color photography, including a ruler to estimate the
             size of the lesion is required.

          -  Adequate organ function including the following:

               -  Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count
                  (ANC) ≥1500 cells/μL, platelet count ≥100,000 cells/μL and hemoglobin ≥9g/dL.

               -  Hepatic: bilirubin ≤ 1.5 X ULN; alanine aminotransferase (ALT) and aspartate
                  aminotransferase (AST) ≤ 3.0 X ULN.

               -  Renal: serum creatinine < 2.0 mg/dL or calculated creatinine clearance >60
                  mL/min.

               -  Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA or
                  echocardiography (intra-patient reassessment of LVEF should be performed via the
                  same method throughout the study).

          -  Negative serum pregnancy test at the time of enrollment for women of child-bearing
             potential. For men and women of child-bearing potential, use of effective
             contraceptive methods during the study.

          -  Ability to understand the requirements of the study, provide written informed consent
             and authorization of use and disclosure of protected health information, and agree to
             abide by the study restrictions and to return for the required assessments.

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  Chest radiotherapy within the previous 28 days or other radiotherapy within the
             previous 14 days. Recovery from the acute toxic effects of radiation required prior to
             study enrollment. Measurable lesions that have been previously irradiated must be
             enlarging to be considered target lesions. Prior radiation therapy allowed to < 25% of
             the bone marrow.

          -  More than 1 prior chemotherapy regiment for SCLC

          -  Prior anthracycline treatment

          -  Treatment with any investigational agent within 28 days or standard chemotherapy
             within 21 days prior to first dose. Patients must have recovered from all acute
             adverse effecxts of prior therapies, excluding alopecia

          -  Patients with secondary primary malignancy (except in situ carcinoma of the cervix or
             adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated
             at least 2 years previously with surgery and/or radiotherapy and no evidence of
             recurrence since that time)

          -  Concurrent severe or uncontrolled medical disease (i.e., active systemic infection,
             diabetes, hypertension, coronary artery disease, congestive heart failure) that, in
             the opinion of the Investigator, would compromise the safety of the patient or
             compromise the ability of the patient to complete the study.

          -  Symptomatic central nervous system metastases. Patients with asymptomatic brain
             metastases are allowed. The patient must be stable after radiotherapy for ≥ 2 weeks
             and off corticosteroids for ≥ 1 week.

          -  History of interstitial lung disease or pulmonary fibrosis.