Molecular Profiling in Lung Cancer Patients
- Conditions
- Non-Small Cell Lung CancerCarcinoma
- Interventions
- Registration Number
- NCT00191308
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pemetrexed + Cisplatin Radical Non-Small Cell Lung Cancer (NSCLC) surgery Pemetrexed: 500 milligrams per square meter (mg/m\^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs Pemetrexed + Cisplatin cisplatin Pemetrexed: 500 milligrams per square meter (mg/m\^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs Pemetrexed + Cisplatin pemetrexed Pemetrexed: 500 milligrams per square meter (mg/m\^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs
- Primary Outcome Measures
Name Time Method High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Objective Tumor Response (Response Rate) Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed) Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.
Duration of Response Time of response to disease progression (up to 44.4 months) The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions.
Disease Free Survival (DFS) Treatment start to disease progression or death from any cause (up to 45.5 months) DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.
Overall Survival (OS) Treatment start to death from any cause (up to 47.6 months) OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇵🇱Warsaw, Poland