Phase 2
N=31
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
Non-small Cell Lung Cancer · Mesothelioma · Lung Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00316225 ↗Enrolled (actual)
31
Serious AEs
38.7%
Results posted
Jul 2010
Primary outcome: Primary: Overview of Adverse Events — 28; 23; 12; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pemetrexed (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overview of Adverse Events |
28; 23; 12; 1; 4; 1 | — |
| SECONDARY Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Pemetrexed Population Pharmacokinetics (PK): Clearance |
85.6 | — |
| SECONDARY Pemetrexed Population Pharmacokinetics: Volume of Distribution |
6.61; 8.91; 1.26 | — |
| SECONDARY Discontinuations Due to Adverse Events |
1; 1; 1; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00316225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.