Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer
- Determine the complete and partial response rates in patients with stage II or IIIA
non-small cell lung cancer treated with neoadjuvant carboplatin, gemcitabine
hydrochloride, and thalidomide.
- Determine, preliminarily, the mechanism of action and activity of thalidomide against
- Determine the 1-year and 2-year survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the operative mortality of patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive carboplatin intravenously (IV) over 30 minutes on day 1, gemcitabine
hydrochloride IV over 30 minutes on days 1 and 8, and oral thalidomide once daily on days
1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity. Within 2-6 weeks after the completion of chemotherapy, patients with
resectable tumors undergo surgical resection.
After completion of study treatment, patients are followed every 3 months for 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients Reporting Clinical Response
Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.
At end of 3 -21 day cycles of treatment
Arkadiusz Dudek, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center||Robbinsdale, Minnesota 55422-2900|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|