Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy
18 Years
N/A
Both
Non-Small Cell Lung Cancer, Carcinoma
Trial Information
Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy
Inclusion Criteria:
- pathologic documentation of non-small cell lung cancer (NSCLC)
- tumor must be accessible by bronchoscopy for tumor tissue sample collection
- patients must have lung cancer with clinical stage IB, II, IIIA
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- patients must not have received prior systemic chemotherapy or radiation therapy for
NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed
between prior surgery and enrolment)
Exclusion Criteria:
- bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast
tumors)
- pregnant or breast feeding patients
- patients who have received treatment within the last 30 days with a drug that has not
received regulatory approval for any indication at the time of study entry
- patients with history or presence of other malignancy except in situ carcinoma of the
skin or prior malignancy treated more than 5 years before without recurrence
(excluding melanoma, breast cancer and hypernephroma)
- unwillingness to take folic acid or vitamin B12 supplementation
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
Outcome Description:
Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.
Outcome Time Frame:
Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/ GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Poland: Ministry of Health
Study ID:
9356
NCT ID:
NCT00191308
Start Date:
May 2005
Completion Date:
December 2010
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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