A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Belotecan; Camptothecin; Topotecan

Criteria

Inclusion Criteria:

• At least 18 years of age

• Histological or cytological diagnosis of SCLC

• Limited disease (LD) or Extensive disease (ED) at time of study entry

• Recurrent or progressive SCLC ≥ 90 days of duration of response for firstline therapy

• Measurable disease defined by RECIST criteria

• ECOG Performance Status of 0, 1, or 2

• Life expectancy ≥ 3 months

• Adequate bone marrow, Renal, Hepatic reserve:

absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/mm3 platelet count ≥ 100,000 cells/ mm3 hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 mm3 Alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤ 2.0 X ULN Alkaline Phosphatase (ALP) ≤ 2.0 X ULN Serum creatinine ≤ 1.5mg/dL or calculated creatinine clearance > 60mL/min

• Signed a written informed consent

Exclusion Criteria:

• Active infection

• Symptomatic brain lesion

• Any other type of cancer during the previous 5 years

• Severe concurrent diseases

• Prior anticancer therapy within 4 weeks before enroll

• Active pregnancy test and Pregnant or nursing women

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