TerminatedInterventionalPhase 2Updated Aug 15, 2023
Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer | NCT00582634 | Trialant
CompletedInterventionalPhase 2Updated Nov 19, 2019
Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer
Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer
ClinicalTrials.gov ID
NCT00582634
Lead Sponsor
University of Wisconsin, MadisonOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
4Actual
Last Update Posted
Nov 19, 2019Actual
Start Date
Sep 2004
Primary Completion Date
Dec 2007Actual
Completion Date
Dec 2007Actual
Official Title
Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer
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
Non Small Cell Lung Cancer
docetaxel and cisplatin
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
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
Primary Purpose
Treatment
Allocation
N/A
Interventional Model
Single Group Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
University of Wisconsin Comprehensive Cancer Center