Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00259285 |
Recruitment Status :
Terminated
(Trial was stopped early due to low enrollment.)
First Posted : November 29, 2005
Results First Posted : June 2, 2009
Last Update Posted : June 2, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small-Cell Lung Cancer | Drug: pemetrexed Drug: cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Alimta (Pemetrexed) and Cisplatin Treatment as Neoadjuvant Therapy in Non Small Cell Lung Cancer |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 3 cycles
Other Names:
Drug: cisplatin 75 mg/m2, intravenous (IV), every 21 days x 3 cycles |
- Treatment Response [ Time Frame: every 21 day cycle (3 cycles) and 3-4 weeks after last cycle ]Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
- Pathologic Remissions After Surgery [ Time Frame: surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy) ]The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.
- Relapse-free Survival [ Time Frame: 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 ]Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259285
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, 48903 | |
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, 08035 | |
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, 15006 | |
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, 28034 | |
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, 31008 | |
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, Spain, 46014 |
Study Director: | 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) | Eli Lilly and Company |
Responsible Party: | Chief Medical Officer, Eli Lilly |
ClinicalTrials.gov Identifier: | NCT00259285 |
Other Study ID Numbers: |
9901 H3E-XM-S092 |
First Posted: | November 29, 2005 Key Record Dates |
Results First Posted: | June 2, 2009 |
Last Update Posted: | June 2, 2009 |
Last Verified: | April 2009 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |