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

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ClinicalTrials.gov Identifier: NCT00316225
Recruitment Status : Completed
First Posted : April 20, 2006
Results First Posted : July 9, 2010
Last Update Posted : July 9, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE April 18, 2006
First Posted Date  ICMJE April 20, 2006
Results First Submitted Date  ICMJE March 10, 2010
Results First Posted Date  ICMJE July 9, 2010
Last Update Posted Date July 9, 2010
Study Start Date  ICMJE December 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
Overview of Adverse Events [ Time Frame: baseline, up to 18 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2006)
  • This study will evaluate the safety and pharmacokinetics of pemetrexed in patients with third-space fluid. This outcome will be fully evaluated once the last patient receiving study treatment has discontinued from study treatment.
  • Secondary: This study will identify increases in the toxicity of pemetrexed, assess the clinical relevance of any alterations in pemetrexed pharmacokinetics and provide pemetrexed dosing recommendations, in patients with third-space fluid.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
  • Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities [ Time Frame: baseline, up to 18 weeks ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • Discontinuations Due to Adverse Events [ Time Frame: baseline, up to 18 weeks ]
    Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 10, 2010)
Overall Tumor Response [ Time Frame: baseline, up to 18 weeks ]
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
Official Title  ICMJE A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • Mesothelioma
  • Lung Neoplasms
Intervention  ICMJE Drug: pemetrexed
500 milligrams per meter squared (mg/m^2) IV every 21 days for 6 cycles
Other Names:
  • LY231514
  • Alimta
Study Arms  ICMJE Experimental: Pemetrexed
Pemetrexed 500 mg/m^2 intravenous (IV) every 21 days for 6 cycles
Intervention: Drug: pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2009)
31
Original Enrollment  ICMJE
 (submitted: April 18, 2006)
48
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Germany,   Spain
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00316225
Other Study ID Numbers  ICMJE 10426
H3E-MC-JMHX ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP