Clinical trial NCT00191308: Molecular Profiling in Lung Cancer Patients
Official title: Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Carcinoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
timeFrame: Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)
Secondary outcomes:
measure: Percentage of Participants With Objective Tumor Response (Response Rate)
timeFrame: Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)
measure: Duration of Response
timeFrame: Time of response to disease progression (up to 44.4 months)
measure: Disease Free Survival (DFS)
timeFrame: Treatment start to disease progression or death from any cause (up to 45.5 months)
measure: Overall Survival (OS)
timeFrame: Treatment start to death from any cause (up to 47.6 months)
Other outcomes:
Locations:
city: Bystra Slaska
country: Poland
facility: 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.
city: Poznan
country: Poland
facility: 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.
city: Warsaw
country: Poland
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: