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OpenTrials
Completed

NCT Number: NCT00582634

Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

* 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

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Docetaxel and Cisplatin

Drug

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 names: Taxotere

Primary outcomes

  1. Time to progression

    Time frame: 36 months

  2. Overall survival

    Time frame: 36 months

  3. Incidence of adverse events

    Time frame: Baseline to 36 months

Secondary outcomes

  1. Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Dec 28, 2007
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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