NCT00316225 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2010-07-09

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities

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outcome · POSTED

Pemetrexed Population Pharmacokinetics (PK): Clearance

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outcome · POSTED

Pemetrexed Population Pharmacokinetics: Volume of Distribution

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outcome · POSTED

Overall Tumor Response

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outcome · POSTED

Discontinuations Due to Adverse Events

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outcome · POSTED

Overview of Adverse Events

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Pemetrexed 500 mg/m\^2 intravenous (IV) every 21 days for 6 cycles
intervention Names
Drug: pemetrexed
label
Pemetrexed
type
EXPERIMENTAL

interventions

arm Group Labels
Pemetrexed
description
500 milligrams per meter squared (mg/m\^2) IV every 21 days for 6 cycles
name
pemetrexed
other Names
LY231514
Alimta
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 31
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions. PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions. SD (stable disease) = small changes that do not meet above criteria.
measure
Overall Tumor Response
time Frame
baseline, up to 18 weeks

primary Outcomes

description
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.
measure
Overview of Adverse Events
time Frame
baseline, up to 18 weeks

secondary Outcomes

description
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.
measure
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
time Frame
baseline, up to 18 weeks
description
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.
measure
Pemetrexed Population Pharmacokinetics (PK): Clearance
time Frame
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
description
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.
measure
Pemetrexed Population Pharmacokinetics: Volume of Distribution
time Frame
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
description
Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.
measure
Discontinuations Due to Adverse Events
time Frame
baseline, up to 18 weeks

Full study description

brief 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.

Source references