Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-09-30

Brief Summary

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Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.

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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 - Before Protocol Amendment

Group Type EXPERIMENTAL

Pemetrexed - Before Protocol Amendment

Intervention Type DRUG

500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue

Pemetrexed - After Protocol Amendment

Group Type EXPERIMENTAL

Pemetrexed - After Protocol Amendment

Intervention Type DRUG

500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.

Interventions

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Pemetrexed - Before Protocol Amendment

500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue

Intervention Type DRUG

Pemetrexed - After Protocol Amendment

500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.

Intervention Type DRUG

Other Intervention Names

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LY231514 Alimta LY231514 Alimta

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven IIIB and IV NSCLC.
* No symptomatic uncontrolled brain metastasis
* Not suitable for platinum containing regimens if chemo-naive
* Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
* Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)

Exclusion Criteria

* Prior radiation to greater than 25% of bone marrow
* Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period.
* Presence of clinically relevant third-space fluid collections not controllable.
* Significant cardiac disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No