Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2004
End Date:December 2007

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Trial Summary
Trial Overview
Inclusion Criteria

Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer

- 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


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
We found this trial at
1
site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin 53792
?
mi
from
Madison, WI
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