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

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.

Tracking Information
First Received DateApril 18, 2006
Last Changed DateJune 10, 2010
Start DateDecember 2006
Actual Primary Completion DateMarch 2009
Primary Outcome Measures

Overview of Adverse Events [Time Frame: baseline, up to 18 weeks]

Secondary Outcome Measures

Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities [Time Frame: baseline, up to 18 weeks]

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]

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]

Discontinuations Due to Adverse Events [Time Frame: baseline, up to 18 weeks]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Non-small Cell Lung Cancer
  • Mesothelioma
  • Lung Neoplasms
Intervention
  • Drug: pemetrexed
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment31
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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.

Administrative Information
NCTIDNCT00316225
Responsible PartyChief Medical Officer, Eli Lilly
SponsorEli Lilly and Company
Verification DateJune 2010
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