A Study for Small Cell Lung Cancer (SCLC) in Extensive Di... | NCT00168896

Studies
A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

NCT00168896

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Feb 14, 2006Estimated

Enrollment

286

Phase

Phase 2Phase 3

Conditions

Small Cell Lung Cancer

Interventions

Carboplatin plus Irinotecan vs Carboplatin plus Etoposide

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2001

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 15, 2005Estimated

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

Feb 13, 2006

Last Update Posted Date

Feb 14, 2006Estimated

Name	Class
Pfizer	INDUSTRY
Aventis Pharmaceuticals	INDUSTRY

Description Module

Brief Summary

Comparison of two combination chemotherapies in the treatment of patients with SLCL

Detailed Description

Comparison of two combination chemotherapies in the treatment of patients with SLCL

The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

286

Name	Type	Description	Arm Group Labels	Other Names
Carboplatin plus Irinotecan vs Carboplatin plus Etoposide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Endpoint:
Documentation of the remission rate ( Phase II)
Determination of progress free time (Phase III)

Secondary Outcomes

Measure	Description	Time Frame
Secondary Endpoint:
Documentation of progress free time (Phase II)
Documentation of objective remission rate ( Phase III)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cytological or histological proven SCLC Stage I or II at 1st diagnosis
no prior chemotherapy
measurable tumor disease
karnofsky performance 70

Exclusion Criteria:

second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
NYHA III
chronic diarrhea, obstructive bowel syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ulrich Keilholz, MD	Contact	+49-30-8445-3596		ulrich.keilholz@charite.de
Alexander Schmittel, MD	Contact	+49-30-8445-3090		alexander.schmittel @charite.de

Overall Officials

Name	Affiliation	Role
Ulrich Keilholz, MD	Charité Campus Benjamin Franklin University Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hematology & Oncology Charité CBF Berlin, Germany	Recruiting	Berlin	State of Berlin	12203	Germany

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016190	Carboplatin
D005047	Etoposide

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes

Browse Leaves

Not provided

Browse Branches

Not provided