Clinical trial NCT00316225: Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
Official title: A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Mesothelioma
Lung Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-04-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overview of Adverse Events
timeFrame: baseline, up to 18 weeks
Secondary outcomes:
measure: Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
timeFrame: baseline, up to 18 weeks
measure: Pemetrexed Population Pharmacokinetics (PK): Clearance
timeFrame: 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
measure: Pemetrexed Population Pharmacokinetics: Volume of Distribution
timeFrame: 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
measure: Discontinuations Due to Adverse Events
timeFrame: baseline, up to 18 weeks
Other outcomes:
measure: Overall Tumor Response
timeFrame: baseline, up to 18 weeks
Locations:
city: Kobenhavn
country: Denmark
facility: 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.
city: Hannover
country: Germany
facility: 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.
city: Madrid
country: Spain
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: