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Chemotherapy for Patients With Non-Small Cell Lung Cancer

NCT ID: NCT00380718

Last Updated: 2010-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC).

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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Pemetrexed

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity\* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease.

\*Toxicity acceptable if none of the following toxicities recorded at any time during Cycle 1: Platelets \<50 x 10\^9/L; absolute neutrophil count \<1.0 x 10\^9/L; Stomatitis/pharyngitis/esophagitis/diarrhea Grade \>2; Skin Grade \>2; Serum bilirubin \>3.0 x upper limit of normal (ULN); alanine aminotransferase/aspartate aminotransferase \>10 x ULN; Other non-hematologic toxicities Grade \>2 (except nausea, vomiting).

Interventions

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pemetrexed

500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity\* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease.

\*Toxicity acceptable if none of the following toxicities recorded at any time during Cycle 1: Platelets \<50 x 10\^9/L; absolute neutrophil count \<1.0 x 10\^9/L; Stomatitis/pharyngitis/esophagitis/diarrhea Grade \>2; Skin Grade \>2; Serum bilirubin \>3.0 x upper limit of normal (ULN); alanine aminotransferase/aspartate aminotransferase \>10 x ULN; Other non-hematologic toxicities Grade \>2 (except nausea, vomiting).

Intervention Type DRUG

Other Intervention Names

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LY231514 Alimta

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
* Patients' NSCLC must have progressed following one chemotherapy regimen for palliative therapy with or without subsequent targeted biological therapy
* Disease status must be that of measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria

* Concurrent administration of any other tumor therapy
* Pregnancy or breast feeding
* Serious concomitant disorders
* Inability or unwillingness to take folic acid or vitamin B12 supplementation
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) or 1-317-615-4559 Mon - Fri 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.

Taichung, , Taiwan

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.

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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H3E-MC-JMIC

Identifier Type: OTHER

Identifier Source: secondary_id

10720

Identifier Type: -

Identifier Source: org_study_id