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Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and gemcitabine together with thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together with thalidomide works in treating patients who are undergoing surgery for stage II or stage III non-small cell lung cancer.
OBJECTIVES: Primary * 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. Secondary * Determine, preliminarily, the mechanism of action and activity of thalidomide against lung cancer. * 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Start Date
May 1, 2002
Primary Completion Date
March 1, 2008
Completion Date
July 1, 2008
Last Updated
December 28, 2017
22
ACTUAL participants
carboplatin
DRUG
gemcitabine hydrochloride
DRUG
thalidomide
DRUG
conventional surgery
PROCEDURE
Lead Sponsor
Masonic Cancer Center, University of Minnesota
NCT06498635
NCT06305754
Data Source & Attribution
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