Molecular Profiling in Lung Cancer Patients
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191308
First received: September 12, 2005
Last updated: October 13, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer Carcinoma |
Drug: pemetrexed Drug: cisplatin Procedure: Radical Non-Small Cell Lung Cancer (NSCLC) surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood [ Time Frame: Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed) ] [ Designated as safety issue: No ]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:
- Percentage of Participants With Objective Tumor Response (Response Rate) [ Time Frame: Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed) ] [ Designated as safety issue: No ]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 Frame: Time of response to disease progression (up to 44.4 months) ] [ Designated as safety issue: No ]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) [ Time Frame: Treatment start to disease progression or death from any cause (up to 45.5 months) ] [ Designated as safety issue: No ]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) [ Time Frame: Treatment start to death from any cause (up to 47.6 months) ] [ Designated as safety issue: No ]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.
| Enrollment: | 30 |
| Study Start Date: | May 2005 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pemetrexed + 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 |
Drug: pemetrexed
500 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
Other Names:
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191308
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191308
Locations
| 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, 43-360 | |
| 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, 60-569 | |
| 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, 02-781 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00191308 History of Changes |
| Other Study ID Numbers: | 9356, H3E-PL-S051 |
| Study First Received: | September 12, 2005 |
| Results First Received: | March 16, 2010 |
| Last Updated: | October 13, 2011 |
| Health Authority: | Poland: Ministry of Health |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Cisplatin |
Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015