Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: December 19, 2007
Last updated: September 30, 2015
Last verified: September 2015
  • 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

Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: docetaxel and cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 36 months ]
  • Incidence of adverse events [ Time Frame: Baseline to 36 months ]

Secondary Outcome Measures:
  • Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: September 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel followed by 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.
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.
Other Name: Taxotere


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00582634

United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Anne Traynor, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison Identifier: NCT00582634     History of Changes
Other Study ID Numbers: H-2004-0248, CO04503
Study First Received: December 19, 2007
Last Updated: September 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
non small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators processed this record on October 02, 2015