Study for Patients With Non Small Cell Lung Cancer (NSCLC) | NCT00168883

Studies
Study for Patients With Non Small Cell Lung Cancer (NSCLC)

NCT00168883

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Nov 1, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin
Paclitaxel
Vinorelbine

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 2006

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 2002

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

Oct 31, 2006

Last Update Posted Date

Nov 1, 2006Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY
Pierre Fabre Pharma GmbH	INDUSTRY

Description Module

Brief Summary

This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.

Detailed Description

Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of response rate (stable disease [SD] or better)
Determination of safety of the combination and life quality

Secondary Outcomes

Measure	Description	Time Frame
Determination of remission rate
Determination of time to progression
Determination of 1-year survival rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV

Exclusion Criteria:

New York Heart Association (NYHA) III or IV
Brain metastases
Neurotoxicity Grade 2 or greater

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

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	Charite University, Berlin, Germany	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

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
D017239	Paclitaxel
D000077235	Vinorelbine

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes

Browse Leaves

Not provided

Browse Branches

Not provided