Clinical trial NCT00259285: Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer
Official title: Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-11-29
Enrollment: 10
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: To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of non-small-cell carcinoma of the lung
* Patients with locally advanced disease or metastatic disease, candidates to surgery after evaluation by oncologist and thoracic surgeon
* Tumour with possibility of curative surgery
* At least one uni-dimensionally measurable lesion
* Adequate pulmonary function to perform the planned surgical resection

Exclusion Criteria:

* Active infection (at the investigator's discretion)
* Pregnancy or breast-feeding
* Serious concomitant illness at the investigator's discretion
* Previous diagnosis of malignant disease
* They have received treatment during the last 30 days with a drug, other than the study drug, that has not received regulatory approval for any indication at the time of their entry in the study

Primary outcomes:
measure: Treatment Response
timeFrame: every 21 day cycle (3 cycles) and 3-4 weeks after last cycle
Secondary outcomes:
measure: Pathologic Remissions After Surgery
timeFrame: surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)
measure: Relapse-free Survival
timeFrame: Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter
Other outcomes:
Locations:
city: Barakaldo
country: Spain
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: Barcelona
country: Spain
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: La Coruña
country: Spain
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: Madrid
country: Spain
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: Pamplona
country: Spain
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: Valencia
country: Spain
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, 1-317-615-4559) Mon-Fri from 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST)
role: STUDY_DIRECTOR
References: