Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer

This study has been completed.

Sponsor:

Collaborator:

Sanofi

Information provided by (Responsible Party):

Michael Mann, Maestro Clinical, Inc.

ClinicalTrials.gov Identifier:

NCT00883675

First received: April 17, 2009

Last updated: January 25, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 17, 2009

Last Updated Date

January 25, 2013

Start Date ^ICMJE

May 2009

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Febrile neutropenia [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00883675 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer

Official Title ^ICMJE

Multicenter Exploratory Trial of the Safety and Efficacy of Adjuvant Docetaxel and Carboplatin in Patients With Resected Non-small Cell Lung Cancer

Brief Summary

The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-small Cell Lung Cancer

Intervention ^ICMJE

Drug: Docetaxel-Carboplatin

Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin AUC 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses

Other Name: Taxotere, Paraplatin

Study Arm (s)

Experimental: Treatment

Intervention: Drug: Docetaxel-Carboplatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

133

Completion Date

December 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Non-small cell lung cancer stage IB - IIIA, complete resection with mediastinal lymph node dissection
ECOG status 0-1
>14 and <56 days since resection

Exclusion Criteria:

Prior chemotherapy and/or radiation therapy for lung cancer
Peripheral neuropathy > grade 1
Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Medical condition that will not permit treatment or follow up according to the protocol
Prior treatment with docetaxel or carboplatin
Hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol
Treatment with other investigational anti-cancer drugs within 30 days of registration
Pregnant or nursing women
HIV-positive patients

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, China

Administrative Information

NCT Number ^ICMJE

NCT00883675

Other Study ID Numbers ^ICMJE

MC#08-002, IIT 12230

Has Data Monitoring Committee

Yes

Responsible Party

Michael Mann, Maestro Clinical, Inc.

Study Sponsor ^ICMJE

Michael Mann

Collaborators ^ICMJE

Sanofi

Investigators ^ICMJE

Principal Investigator:

David Jablons, MD

Maestro Clinical

Information Provided By

Maestro Clinical, Inc.

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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