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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883675
• Other study ID #: MC#08-002
• Secondary ID: IIT 12230
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2009
• Last updated: October 29, 2013
• Start date: May 2009
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: Maestro Clinical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
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
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Michael Mann	Sanofi

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Febrile Neutropenia	The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.	2 months	Yes