Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Cisplatin; Docetaxel

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