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

Chong Kun Dang

Status and phase

Completed

Phase 2

Conditions

Small Cell Lung Cancer

Treatments

Drug: Belotecan

Drug: Topotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01497873

11SCLC09I

Details and patient eligibility

About

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.

Full description

A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell inj.) or Topotecan in Patients with Relapsed Small Cell Lung Cancer

Enrollment

164 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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