Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: docetaxel and cisplatin

• 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

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-28
• Status Verified: 2015-09
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

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

Trial Locations

Locations (1)

University of Wisconsin Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States