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NCT00259285 Clinical Trial

Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer

Non-Small-Cell Lung Cancer Clinical Trial

Official title:
Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00259285
Other study ID # 9901
Secondary ID H3E-XM-S092
Status Terminated
Phase Phase 2
First received November 28, 2005
Last updated April 7, 2009
Start date November 2005
Est. completion date December 2007

Study information
Verified date April 2009
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Interventional

Clinical Trial Summary

To determine the response to this regimen for therapy prior surgery in patients with locally advanced disease or metastatic disease.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Intervention

Drug:
• pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
• cisplatin
75 mg/m2, intravenous (IV), every 21 days x 3 cycles

Locations
Country Name City State
Spain 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. Barakaldo
Spain 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. Barcelona
Spain 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. La Coruña
Spain 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. Madrid
Spain 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. Pamplona
Spain 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. Valencia

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment Response every 21 day cycle (3 cycles) and 3-4 weeks after last cycle No
Secondary Pathologic Remissions After Surgery surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy) No
Secondary Relapse-Free Survival 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 No
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