A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349492
• Other study ID #: CRCST-L-0001
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2006
• Last updated: December 3, 2013
• Start date: June 2006
• Est. completion date: October 2013

Study information

• Verified date: March 2012
• Source: Clinical Research Center for Solid Tumor, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms.

Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks

Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1.5 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: October 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically diagnosed small cell lung cancer

• Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion)

• If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment)

• No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy)

• One or more measurable disease by RECIST criteria

• at least 18 years of age

• Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria

• Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function

• Informed consent from patient which conforms to Institutional Review Board

Exclusion Criteria:

• History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years

• Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease

• Uncontrolled serious infection

• Enrollment in other study within 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• IP
irinotecan+cisplatin

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon-si
Korea, Republic of	Daegu Catholic University Hospital	Daegu
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-Si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kangnam St.Mary's Hospital	Seoul
Korea, Republic of	Seoul Municipal Boramae Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul Veterans Hospital	Seoul
Korea, Republic of	Yonsei Cancer Center	Seoul
Korea, Republic of	St.Vincent Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Center for Solid Tumor, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		month	No
Secondary	Objective response rate		percent	No
Secondary	Progression free survival		month	No
Secondary	Safety profile		percent	Yes