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

Phase 2
18 Years
Not Enrolling
Non Small Cell Lung Cancer

Thank you

Trial Information

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

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

- Uncontrolled cardiac disease or uncontrolled hypertension

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression, overall survival, safety

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Anne Traynor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Institutional Review Board

Study ID:




Start Date:

September 2004

Completion Date:

December 2007

Related Keywords:

  • Non Small Cell Lung Cancer
  • non small cell lung cancer
  • adjuvant
  • cisplatin
  • docetaxel
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792