Molecular and Genetic Changes in Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Cisplatin and Alimta - Phase II Study
PRIMARY OBJECTIVES:
I. The primary goal is to determine whether or not these two agents given prior to surgery
increase the chance that the surgical specimen will be pathologically negative (pathological
complete response).
SECONDARY OBJECTIVES:
I. Document adverse events using this regimen in this setting. II. To document the overall
and disease free survival. III. To correlate response with markers such as presence or
absence of excision nuclease within the nucleotide excision repair 1 (ERCC1) and
dihydrofolate reductase (DHFR), thymidylate synthase (TS), dihydropyrimidine dehydrogenase
(DPD) and glycinamide ribonucleotide formyl transferase (GARFT).
IV. Correlate pre- and post chemotherapy effects on fludeoxyglucose F18 (FDG) uptake by the
tumor on positron emission tomography (PET) scan.
OUTLINE:
NEOADJUVANT CHEMOTHERAPY: Patients receive pemetrexed disodium intravenously (IV) over 10
minutes and cisplatin IV over approximately 1 hour on days 1, 22, and 43. Treatment repeats
every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients undergo surgery between days 70-90.
ADJUVANT CHEMOTHERAPY: Beginning on day 130, patients receive pemetrexed disodium and
cisplatin as in neoadjuvant chemotherapy. Treatment repeats every 21 days for 2 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then yearly thereafter.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response
Up to day 63
No
Grace Dy
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
I 31104
NCT01731626
June 2005
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Rochester General Hospital | Rochester, New York 14621 |