Phase II Prospective Study Evaluating the Role of Directed Cisplatin Based Chemo With Either Vinorelbine or Pemetrexed for the Adj Tx of Early Stage NSCLC in Patients Using Genomic Expression Profiles of Chemo Sensitivity to Guide Therapy
The proposed study is a multi-center open label phase II study of the chemotherapy doublets
cisplatin/vinorelbine and cisplatin/pemetrexed as adjuvant therapy in early stage
non-squamous NSCLC.
Eligible patients will have no previous treatment for the current diagnosis of non-squamous
NSCLC. The two treatment groups of patients will be determined by gene expression profile
analysis of each patient's tumor: one group of vinorelbine-sensitive patients and one group
of pemetrexed-sensitive patients. The genomic expression profiling that will be utilized
generates a percentage for likelihood of chemotherapy sensitivity. Patients will be directed
to receive the chemotherapy regimen for which the percentage of predicted sensitivity is
highest. For instance, if the model predicted the likelihood of tumor sensitivity was 46% to
vinorelbine and 48% to pemetrexed, then the adjuvant chemotherapy would be directed to
cisplatin/pemetrexed. Patients whose tumors cannot be adequately analyzed for gene
expression will be offered adjuvant therapy off protocol as deemed appropriate by their
primary oncologist.
One hundred and seventeen patients with stage IB (> 4 cm), II or IIIA non-squamous NSCLC
will be enrolled. The vinorelbine-sensitive tumors group will receive Vinorelbine 25 mg/m2
days 1 and 8, followed by cisplatin 75 mg/m2 day 1, every 21 days for 4 cycles. The
pemetrexed-sensitive tumors group will receive pemetrexed 500 mg/m2 day 1 followed by
cisplatin 75 mg/m2 day 1, every 21 days for 4 cycles. Standard pre-medication regimens will
include dexamethasone, vitamin B12 and folate supplementation in the pemetrexed group.
Patients in both groups will receive up to a maximum of 4 cycles of therapy.
A pilot study is appropriate in this case because currently there is not a defined clinical
role for genomics technology in determining therapy for NSCLC. The two chemotherapy regimens
provided to the study patients are active agents in the treatment of non-squamous NSCLC.
Study treatment will consist of 4 cycles of chemotherapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess if adjuvant chemotherapy using genomic expression profiles to direct sensitivity to vinorelbine or pemetrexed chemotherapy can increase two year disease-free survival rate in completely resected non-squamous NSCLC
2 years
No
Neal Ready, Ph.D., M.D.
Principal Investigator
Duke University Medical Center, Hematology/Oncology, Duke Comprehensive Cancer Center
United States: Institutional Review Board
Pro00000657
NCT00545948
October 2007
June 2013
Name | Location |
---|---|
Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
Coastal Cancer Center | Myrtle Beach, South Carolina 29572 |
Community Memorial Health Center | South Hill, Virginia 23970-0090 |
Maria Parham Hospital | Henderson, North Carolina 27536 |
Duke Raleigh Hospital | Raleigh, North Carolina 27609 |
Scotland HealthCare System (Scotland Memorial Hospital) | Laurinburg, North Carolina 28352 |
Southeastern Regional Medical Center, Gibson Cancer Center | Lumberton, North Carolina 28358 |
Beaufort Memorial Hospital | Beaufort, South Carolina 29902 |
Johnston Memorial Hospital Authority | Smithfield, North Carolina 27577 |
Columbus County Hospital | Whiteville, North Carolina 28472 |