Clinical trial NCT00349492: A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: Small Cell Lung Cancer
Extensive Disease
Chemotherapy
Randomisation
Lead sponsor: Clinical Research Center for Solid Tumor, Korea
Sponsor class: OTHER
First posted: 2006-07-07
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: month
Secondary outcomes:
measure: Objective response rate
timeFrame: percent
measure: Progression free survival
timeFrame: month
measure: Safety profile
timeFrame: percent
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul Veterans Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Municipal Boramae Hospital
city: Suwon
country: Korea, Republic of
facility: St.Vincent Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Dae Seog Heo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: