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: October 29, 2013
Last verified: October 2013

April 17, 2009
October 29, 2013
May 2009
September 2012   (final data collection date for primary outcome measure)
Febrile Neutropenia [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.
Febrile neutropenia [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00883675 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer
Multicenter Exploratory Trial of the Safety and Efficacy of Adjuvant Docetaxel and Carboplatin in Patients With Resected Non-small Cell Lung Cancer

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.

Patients with stage Ib - IIIa NSCLC participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
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
Experimental: Treatment
Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
Intervention: Drug: Docetaxel-Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
December 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   United States
 
NCT00883675
MC#08-002, IIT 12230
Yes
Michael Mann, Maestro Clinical, Inc.
Michael Mann
Sanofi
Principal Investigator: David Jablons, MD Maestro Clinical
Maestro Clinical, Inc.
October 2013

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