Non Small Cell Lung Cancer Clinical Trial
Official title:
Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer
Verified date | September 2015 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- 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
Status | Completed |
Enrollment | 4 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to progression | 36 months | ||
Primary | Overall survival | 36 months | ||
Primary | Incidence of adverse events | Baseline to 36 months | ||
Secondary | Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities | 36 months |
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