Status:
TERMINATED
Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer
Lead Sponsor:
Providence Health & Services
Collaborating Sponsors:
Providence Cancer Center, Earle A. Chiles Research Institute
Sanofi
Conditions:
Non-small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to assess the response rate of treatment with two cycles of cisplatin and docetaxel chemotherapy prior to surgery (neoadjuvant) for early stage non-small cell lu...
Detailed Description
Non-small cell lung cancer (NSCLC) accounts for 80% of new lung cancer diagnoses in the US. Surgery is the primary most successful treatment for early stage patients. However, even lung cancers caught...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed NSCLC appropriate for surgery
- Medically fit for resection by lobectomy or pneumonectomy
- T1-2N1 disease by CT must have negative N2/N3 nodes by PET
- T3N1 disease must have pathologically negative N2/N3 nodes
- Measurable disease
- Patients must not be receiving other investigational therapy
- Prior surgery for NSCLC okay if resected \> or = 5 years prior
- No prior chemotherapy or radiation for NSCLC
- No uncontrolled medical problems
- No factors that would preclude obtaining informed consent
- Age 18 or greater
- Performance status (PS) 0-1
- Peripheral neuropathy must be \< grade 1
- Acceptable hematologic and chemistry parameters
- Renal: creatinine clearance (calculated) \> 50 cc/min
Exclusion
- History of severe hypersensitivity to docetaxel or like drugs
- Pregnant or nursing women
- Prior chemotherapy or radiation for NSCLC
- Symptomatic superior sulcus tumors
- Prior malignancy except for treated non-melanoma skin cancer, in situ cervical cancer, localized prostate cancer or cancer from which the patient has been disease free for greater than three years
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00232206
Start Date
May 1 2005
End Date
November 1 2007
Last Update
May 18 2011
Active Locations (1)
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1
Providence Portland Medical Center
Portland, Oregon, United States, 97213