Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III 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.
Drug: gemcitabine hydrochloride
Procedure: conventional surgery
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer|
- Number of Patients Reporting Clinical Response [ Time Frame: At end of 3 -21 day cycles of treatment ] [ Designated as safety issue: No ]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.
- Number of Patients Disease-free at 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]Calculated from date of enrollment to date of recurrence or death, whichever came first
- Number of Patients Disease-free at 2 Years [ Time Frame: 2 Years ] [ Designated as safety issue: No ]Calculated from date of enrollment to date of recurrence or death, whichever came first
- Number of Patients Alive at 1 Year (Survival) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]Participants who were alive at one year from date of enrollment .
- Number of Patients Alive at 2 Years (Survival) [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]Participants who were alive at 2 years from date of enrollment.
- Number of Patients Alive at 56 Months (End of Study) [ Time Frame: Up to 56 months ] [ Designated as safety issue: Yes ]Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).
|Study Start Date:||May 2002|
|Study Completion Date:||July 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.
Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)
Other Name: PARAPLATINDrug: gemcitabine hydrochloride
Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.
Other Name: GemzarDrug: thalidomide
Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.
Other Name: ThalidomidProcedure: conventional surgery
Resection - between 2 and 6 weeks following last dose of chemotherapy.
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281827
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center|
|Robbinsdale, Minnesota, United States, 55422-2900|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Study Chair:||Arkadiusz Dudek, MD||Masonic Cancer Center, University of Minnesota|