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

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316225
• Other study ID #: 10426
• Secondary ID: H3E-MC-JMHX
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2006
• Last updated: June 10, 2010
• Start date: December 2006
• Est. completion date: March 2009

Study information

• Verified date: June 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Mesothelioma
• Non-small Cell Lung Cancer

Intervention

Drug:
• pemetrexed
500 milligrams per meter squared (mg/m^2) IV every 21 days for 6 cycles

Locations

Country	Name	City	State
Denmark	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.	Kobenhavn
Germany	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.	Hannover
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Denmark,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overview of Adverse Events	Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	baseline, up to 18 weeks	Yes
Secondary	Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities	Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening.; NOS = Not otherwise specified.	baseline, up to 18 weeks	Yes
Secondary	Pemetrexed Population Pharmacokinetics (PK): Clearance	Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma.	Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion	Yes
Secondary	Pemetrexed Population Pharmacokinetics: Volume of Distribution	Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment.	Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion	Yes
Secondary	Discontinuations Due to Adverse Events	Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.	baseline, up to 18 weeks	Yes

External Links

•   Lilly Clinical Trial Registry