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

This study has been completed.
Information provided by (Responsible Party):
Michael Mann, Maestro Clinical, Inc. Identifier:
First received: April 17, 2009
Last updated: October 29, 2013
Last verified: October 2013
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 Intervention Phase
Non-small Cell Lung Cancer
Drug: Docetaxel-Carboplatin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Maestro Clinical, Inc.:

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

Enrollment: 133
Study Start Date: May 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00883675

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
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
Principal Investigator: David Jablons, MD Maestro Clinical
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Mann, Director, Maestro Clinical, Inc. Identifier: NCT00883675     History of Changes
Other Study ID Numbers: MC#08-002
IIT 12230
Study First Received: April 17, 2009
Results First Received: October 29, 2013
Last Updated: October 29, 2013

Keywords provided by 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
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017