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Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00582634
First Posted: December 28, 2007
Last Update Posted: October 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
  • 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: Intervention Model: Single Group Assignment
Masking: None (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 ]
  • 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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582634


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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582634     History of Changes
Other Study ID Numbers: H-2004-0248
CO04503
First Submitted: December 19, 2007
First Posted: December 28, 2007
Last Update Posted: October 2, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action