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

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ClinicalTrials.gov Identifier: NCT00883675
Recruitment Status : Completed
First Posted : April 20, 2009
Results First Posted : December 18, 2013
Last Update Posted : December 18, 2013
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Michael Mann, Maestro Clinical, Inc.

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Docetaxel-Carboplatin Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Exploratory Trial of the Safety and Efficacy of Adjuvant Docetaxel and Carboplatin in Patients With Resected Non-small Cell Lung Cancer
Study Start Date : May 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. Febrile Neutropenia [ Time Frame: 2 months ]
    The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883675


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
China
Beijing Chaoyang Hospital
Beijing, China
Beijing Tumor Hospital
Beijing, China
Beijing Youyi Hospital
Beijing, China
China-Japan Friendship Hospital
Beijing, China
Xuanwu Hospital
Beijing, China
First Affiliated Hospital, Guangzhou Medical College
Guangzhou, China
Sun Yat-sen Cancer Center
Guangzhou, China
Shanghai Chest Hopsital, Pulmonary Medicine
Shanghai, China
Shanghai Lung Cancer Center, Shanghai Chest Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Tianjin Cancer Center
Tianjin, China
Sponsors and Collaborators
Michael Mann
Sanofi
Investigators
Principal Investigator: David Jablons, MD Maestro Clinical

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Mann, Director, Maestro Clinical, Inc.
ClinicalTrials.gov Identifier: NCT00883675     History of Changes
Other Study ID Numbers: MC#08-002
IIT 12230
First Posted: April 20, 2009    Key Record Dates
Results First Posted: December 18, 2013
Last Update Posted: December 18, 2013
Last Verified: October 2013

Keywords provided by Michael Mann, Maestro Clinical, Inc.:
Lung cancer
Adjuvant therapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Carboplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action