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
  Purpose

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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Lung Cancer Center, Shanghai Chest Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Shanghai Chest Hopsital, Pulmonary Medicine
Shanghai, China
Tianjin Cancer Center
Tianjin, China
Sponsors and Collaborators
Michael Mann
Sanofi
Investigators
Principal Investigator: David Jablons, MD Maestro Clinical
  More Information

No publications provided

Responsible Party: Michael Mann, Director, Maestro Clinical, Inc.
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board
China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 22, 2014