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

Status: Completed
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ 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

Locations
Other Locations
Republic of Korea
Chungbuk University Hospital
Daegu
Keimyung University Dongsan Center
Daegu
National Cancer Center
Goyang
Asan Medical Center
Seoul
CHA Bundang Medical Center
Seoul
Chung-Ang University hospital
Seoul
Kyung Hee University Medical Hospital
Seoul
Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul St. Marys Hospital
Seoul
Seoul Veterans Hospital
Seoul
Yonsei Cancer Center
Seoul
Ajou University Hospital
Suwon
St. Vincents Hospital
Suwon
Time Frame
Start Date: September 2010
Completion Date: March 2018
Participants
Target number of participants: 164
Treatments
Experimental: Belotecan
Camtobell Injection
Active Comparator: Topotecan
Hycamtin Injection
Authors
Jin Young Kim, Bong Seog Kim, Jin Soo Kim, Jin Hyuk Choi, Chi Hoon Maeng, Ho Jung An, Jin Hyoung Kang, Joung Soon Jang, Dong-Wan Kim, Jae Heon Jeong, Dong Wan Kim, Heung Tai Kim, Ki Hyeong Lee, Hye Ryeon Kim, Jin-Soo Kim, Sang-We Kim, Sang We Kim, Joo-Hang Kim, Hong Suk Song, Hoon Kyo Kim, Heung Tae Kim
Sponsors
Leads: Chong Kun Dang Pharmaceutical

This content was sourced from clinicaltrials.gov

Similar Clinical Trials