Back to resultsAdjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel and cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring non small cell lung cancer, adjuvant, cisplatin, docetaxel
Eligibility Criteria
Inclusion Criteria:
- Stage IB to IIIA non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study
- Performance Status ECOG 0 or 1
- Peripheral neuropathy: < grade 1
- Adequate blood cell counts
- Adequate liver and hepatic function
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Exclusion Criteria:
- Patients with a history of severe hypersensitivity reaction to Docetaxel® or other drugs formulated with polysorbate 80.
- Women who are breast-feeding.
- Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively)
- Uncontrolled cardiac disease or uncontrolled hypertension
Sites / Locations
- University of Wisconsin Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Docetaxel followed by cisplatin
Arm Description
Docetaxel (75mg/m2) given IV followed by cisplatin (75mg/m2) given IV on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for 4 cycles.
Outcomes
Primary Outcome Measures
Time to progression
Overall survival
Incidence of adverse events
Secondary Outcome Measures
Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities
Full Information
NCT ID
NCT00582634
First Posted
December 19, 2007
Last Updated
November 15, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00582634
Brief Title
Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer
Official Title
Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer
To evaluate the time to progression and overall survival
To evaluate toxicities of this chemotherapy combination in the adjuvant setting
To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in patients treated with this regimen
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
non small cell lung cancer, adjuvant, cisplatin, docetaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docetaxel followed by cisplatin
Arm Type
Experimental
Arm Description
Docetaxel (75mg/m2) given IV followed by cisplatin (75mg/m2) given IV on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
docetaxel and cisplatin
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel (75mg/m2) followed by cisplatin (75mg/m2) on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for4 cycles.
Primary Outcome Measure Information:
Title
Time to progression
Time Frame
36 months
Title
Overall survival
Time Frame
36 months
Title
Incidence of adverse events
Time Frame
Baseline to 36 months
Secondary Outcome Measure Information:
Title
Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage IB to IIIA non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study
Performance Status ECOG 0 or 1
Peripheral neuropathy: < grade 1
Adequate blood cell counts
Adequate liver and hepatic function
Women of childbearing potential must have a negative pregnancy test.
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Exclusion Criteria:
Patients with a history of severe hypersensitivity reaction to Docetaxel® or other drugs formulated with polysorbate 80.
Women who are breast-feeding.
Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively)
Uncontrolled cardiac disease or uncontrolled hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Traynor, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Links:
URL
https://cancer.wisc.edu
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer
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