Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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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

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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: docetaxel and cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel followed by cisplatin<br>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<br>* 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.<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | 36 months | 
| Overall survival |  | 36 months | 
| Incidence of adverse events |  | Baseline to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non small cell lung cancer, adjuvant, cisplatin, docetaxel