Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-03-31

Brief Summary

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This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer Mesothelioma Lung Neoplasms

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

Pemetrexed 500 mg/m\^2 intravenous (IV) every 21 days for 6 cycles

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

500 milligrams per meter squared (mg/m\^2) IV every 21 days for 6 cycles

Interventions

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pemetrexed

500 milligrams per meter squared (mg/m\^2) IV every 21 days for 6 cycles

Intervention Type DRUG

Other Intervention Names

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LY231514 Alimta

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) or mesothelioma
* Presence of third-space fluid (fluid around the lungs or abdomen).
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the sharp toxic effects the anticancer treatment.
* Estimated life expectancy of at least 8 weeks.

Exclusion Criteria

* Have received treatment within the last 30 days with a drug that was not a marketed product.
* Active infection that, in the opinion of the investigator, would not allow the patient to tolerate therapy.
* Pregnancy.
* Breast-feeding.
* Significant weight loss (that is, greater than or equal to 10% of body weight) over the 6 weeks before study entry.
* Brain metastases.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No