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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Docetaxel-Carboplatin
Sponsored by
Michael Mann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Lung cancer, Adjuvant therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center
  • Beijing Chaoyang Hospital
  • Beijing Tumor Hospital
  • Beijing Youyi Hospital
  • China-Japan Friendship Hospital
  • Xuanwu Hospital
  • First Affiliated Hospital, Guangzhou Medical College
  • Sun Yat-sen Cancer Center
  • Shanghai Chest Hopsital, Pulmonary Medicine
  • Shanghai Lung Cancer Center, Shanghai Chest Hospital
  • Shanghai Pulmonary Hospital
  • Tianjin Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Febrile Neutropenia
The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2009
Last Updated
October 29, 2013
Sponsor
Michael Mann
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00883675
Brief Title
Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Mann
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Lung cancer, Adjuvant therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Docetaxel-Carboplatin
Other Intervention Name(s)
Taxotere, Paraplatin
Intervention Description
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
Primary Outcome Measure Information:
Title
Febrile Neutropenia
Description
The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Jablons, MD
Organizational Affiliation
Maestro Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Beijing Chaoyang Hospital
City
Beijing
Country
China
Facility Name
Beijing Tumor Hospital
City
Beijing
Country
China
Facility Name
Beijing Youyi Hospital
City
Beijing
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Facility Name
Xuanwu Hospital
City
Beijing
Country
China
Facility Name
First Affiliated Hospital, Guangzhou Medical College
City
Guangzhou
Country
China
Facility Name
Sun Yat-sen Cancer Center
City
Guangzhou
Country
China
Facility Name
Shanghai Chest Hopsital, Pulmonary Medicine
City
Shanghai
Country
China
Facility Name
Shanghai Lung Cancer Center, Shanghai Chest Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China
Facility Name
Tianjin Cancer Center
City
Tianjin
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24255769
Citation
Zhi X, Gao W, Han B, Yang Y, Li H, Liu D, Wang C, Min G, Long H, Rigas JR, Carey M, Jahan T, Sammann A, Reza J, Wang D, Mann MJ, Jablons DM, He J; China Clinical Trials Consortium. VATS lobectomy facilitates the delivery of adjuvant docetaxel-carboplatin chemotherapy in patients with non-small cell lung cancer. J Thorac Dis. 2013 Oct;5(5):578-84. doi: 10.3978/j.issn.2072-1439.2012.02.05.
Results Reference
derived

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

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