Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582634
• Other study ID #: H-2004-0248
• Secondary ID: CO04503H-2004-02
• Status: Completed
• Phase: Phase 2
• Start date: September 2004
• Est. completion date: December 2007

Study information

• Verified date: September 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• docetaxel and cisplatin
Docetaxel (75mg/m2) followed by cisplatin (75mg/m2) on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for4 cycles.

Locations

Country	Name	City	State
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   University of Wisconsin Carbone Cancer Center