Molecular Profiling in Lung Cancer Patients

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191308
• Other study ID #: 9356
• Secondary ID: H3E-PL-S051
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: October 13, 2011
• Start date: May 2005
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• pemetrexed
500 mg/m^2 IV 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

Procedure:
• Radical Non-Small Cell Lung Cancer (NSCLC) surgery
All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.

Locations

Country	Name	City	State
Poland	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.	Bystra Slaska
Poland	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.	Poznan
Poland	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood	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.	Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)	No
Secondary	Percentage of Participants With Objective Tumor Response (Response Rate)	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.	Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)	No
Secondary	Duration of Response	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.	Time of response to disease progression (up to 44.4 months)	No
Secondary	Disease Free Survival (DFS)	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.	Treatment start to disease progression or death from any cause (up to 45.5 months)	No
Secondary	Overall Survival (OS)	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.	Treatment start to death from any cause (up to 47.6 months)	No

External Links

•   Lilly Clinical Trial Registry