A Study Comparing Etoposide/Cisplatin With Irinotecan/Cis... | NCT00349492

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Dec 2011Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jul 5, 2006

First Submission Date that Met QC Criteria

Jul 5, 2006

First Posted Date

Jul 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2013

Last Update Posted Date

Dec 4, 2013Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

372Estimated

Label	Type	Description	Intervention Names
EP	Active Comparator	etoposide + cisplatin	Drug: IP

Name	Type	Description	Arm Group Labels	Other Names
IP	Drug	irinotecan+cisplatin	EP	irinotecan + cisplatin

Measure	Description	Time Frame
Overall survival		month

Measure	Description	Time Frame
Objective response rate		percent
Progression free survival		month
Safety profile

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Soonchunhyang University Bucheon Hospital		Bucheon-si		420-767	South Korea
Yeungnam University Hospital

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D000077146	Irinotecan
D002945	Cisplatin

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds