Oxaliplatin/CPT-11 for Extensive Stage Small Cell Lung Ca... | NCT00316433

Studies
Oxaliplatin/CPT-11 for Extensive Stage Small Cell Lung Cancer

NCT00316433

Sponsor

Swedish Medical Center

Status

Terminated

Last Update Posted

Apr 5, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Small Cell Lung Cancer

Interventions

Irinotecan (CPT-11)
Oxaliplatin (Eloxatin)

Countries

United States

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

Apr 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Feb 2005

Primary Completion Date

Not provided

Completion Date

Jan 2007Actual

First Submitted Date

Apr 18, 2006

First Submission Date that Met QC Criteria

Apr 18, 2006

First Posted Date

Apr 20, 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

Apr 4, 2007

Last Update Posted Date

Apr 5, 2007Estimated

Name	Class
Sanofi-Synthelabo	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine the safety and effectiveness of the combination of oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small cell lung cancer.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previously untreated extensive small cell lung cancer
No prior chemotherapy
No prior radiotherapy except for the treatment of brain metastases

Exclusion Criteria:

Prior treatment for extensive stage small cell lung cancer
Known hypersensitivity to any of the components of oxaliplatin or CPT-11
Greater than grade 2 peripheral neuropathy
Known HIV or Hepatitis B or C (active, previously treated or both)

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

Not provided

Overall Officials

Name	Affiliation	Role
Howard (Jack) West, MD	Swedish Medical Center Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swedish Medical Center Cancer Institute		Seattle	Washington	98104	United States

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
D000077146	Irinotecan
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D056831	Coordination Complexes

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Irinotecan (CPT-11)	Drug
Oxaliplatin (Eloxatin)	Drug