Mesothelioma Related Clinical Trials:
A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid

In Page Navigation: - General Info - Purpose - Eligibility - Contacts & Locations - Additional Information

   

Status: Recruiting
Sponsors and Collaborators: Eli Lilly and Company
Information provided by: Eli Lilly and Company
Government Identifier: NCT00316225

Condition: Non-Small Cell Lung Cancer; Mesothelioma; Lung Neoplasms
Intervention: Drug: pemetrexed

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Purpose:


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

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: cycle 1, cycle 2 ] [ Designated as safety issue: Yes ]
  • Pemetrexed dosing recommendations [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   30
Study Start Date:   December 2006
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental Drug: pemetrexed
500 mg/m2, IV, q 21 days x 6 cycles

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Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer or mesothelioma
  • Presence of third-space fluid (fluid around the lungs or abdomen).
  • Measurable lesions are not required for enrollment in this study.
  • 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.

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316225

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or     1-317-615-4559    
Locations
Denmark
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.     Recruiting
      København, Denmark, 2100
      Contact: Eli Lilly            
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.     Recruiting
      Odense, Denmark, 5000
      Contact: Eli Lilly            
Germany
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.     Recruiting
      Hannover, Germany, D-30625
      Contact: Eli Lilly            
Spain
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.     Recruiting
      Madrid, Spain, 28041
      Contact: Eli Lilly            

Sponsors and Collaborators
Eli Lilly and Company

Investigators
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    

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Additional Information:

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   10426, H3E-MC-JMHX
First Received:   April 18, 2006
Last Updated:   January 21, 2008
ClinicalTrials.gov Identifier:   NCT00316225
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Lung Neoplasms
Lung Diseases
Mesothelioma
Adenoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Mesothelioma
Antimetabolites
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Therapeutic Uses

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