Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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 lung cancer (NSCLC). Secondary objectives of this study include assessment of radiographic response rate by computed tomography (CT) scanning, overall survival, time to progression, rate of complete surgical removal, and adverse reactions. In addition, this study will test whether positron emission tomography (PET) imaging can predict a tumor response. Patients who have a response to chemotherapy may receive 2 additional cycles after recovering from surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Providence Health & Services
• Collaborators: Providence Cancer Center, Earle A. Chiles Research Institute; Sanofi
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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