A Randomized Phase 2 Trial Comparing Amrubicin Versus Topotecan as Second-Line Treatment in Patients With Extensive Small Cell Lung Cancer Sensitive to First-Line Chemotherapy

Inclusion Criteria:

- Histological or cytological diagnosis of SCLC

- Extensive disease (ED) at time of study entry

- Response to first-line platinum-based chemotherapy

- Recurrent or progressive SCLC ≥90 days after completion of first-line therapy

- 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 leions are clearly defined and surrounded by aerated
lung. Clinically detected lesions will only be considered measurable when they are
superficial (eg., 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 ≥9 g/dL

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

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

- Cardiac: Left ventricular ejection fraction (LVEF) ≥50%

- Negative serum pregnancy test at the time of enrollment for women of child-bearing
potential. For men and women of child-producing 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 regimen for SCLC

- Prior anthracycline treatment

- Participation in any investigational drug study within 28 days prior to study entry

- Patients with second primary malignancy (except in situ carcinoma of the cervix or
adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated
at least 5 years previously with no evidence of recurrence; prior low grade [Gleason
score ≤6] localized prostate cancer is allowed)

- 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