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

NCT ID: NCT00259285

Last Updated: 2009-06-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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Conditions

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Non-Small-Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

500 mg/m2, intravenous (IV), every 21 days x 3 cycles

cisplatin

Intervention Type DRUG

75 mg/m2, intravenous (IV), every 21 days x 3 cycles

Interventions

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pemetrexed

500 mg/m2, intravenous (IV), every 21 days x 3 cycles

Intervention Type DRUG

cisplatin

75 mg/m2, intravenous (IV), every 21 days x 3 cycles

Intervention Type DRUG

Other Intervention Names

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LY231514 Alimta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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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

Eli Lilly and Company

Locations

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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.

A Coruña, , Spain

Site Status

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

Site Status

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

Site Status

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

Site Status

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

Site Status

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

Site Status

Countries

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Spain

Other Identifiers

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H3E-XM-S092

Identifier Type: -

Identifier Source: secondary_id

9901

Identifier Type: -

Identifier Source: org_study_id

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