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

Lilly

Status and phase: Completed; Phase 2

Conditions: Lung Neoplasms; Non-small Cell Lung Cancer; Mesothelioma

Treatments: Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316225

10426

H3E-MC-JMHX (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Pemetrexed

Experimental group

Description:

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

Treatment:

Drug: pemetrexed