Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer
- Registration Number
- NCT00582634
- Lead Sponsor
- University of Wisconsin, Madison
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Docetaxel followed by cisplatin docetaxel and cisplatin 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.
- Primary Outcome Measures
Name Time Method Time to progression 36 months Incidence of adverse events Baseline to 36 months Overall survival 36 months
- Secondary Outcome Measures
Name Time Method Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities 36 months
Related Research Topics
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Trial Locations
- Locations (1)
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center🇺🇸Madison, Wisconsin, United States