Mesothelioma Related Clinical Trials:
ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial

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

   

Status: Completed
Sponsors and Collaborators: Eli Lilly and Company
Information provided by: Eli Lilly and Company
Government Identifier: NCT00061451

Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: Pemetrexed; Drug: Gemcitabine

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Purpose:


The purposes of this study are to determine:

  1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
  2. Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.
  3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
  4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.
Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To assess the anti-tumor activity of pemetrexed plus gemcitabine for patients with malignant pleural or peritoneal mesothelioma

Secondary Outcome Measures:
  • To assess objective tumor response for responding patients
  • To assess duration of response for responding patients
  • To assess time to treatment failure for patients
  • To assess progression free survival of patients
  • To assess time to progressive disease for patients
  • To assess survival time for patients
  • To determine toxicities of pemetrexed in combination with cisplatin or carboplatin in this population

Estimated Enrollment:   48
Study Start Date:   December 2002
Estimated Study Completion Date:   September 2006

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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 Non-Small Cell Lung Cancer that can be treated with chemotherapy.
  • Have received no prior chemotherapy for Non-Small Cell Lung Cancer.
  • Have at least one measurable lesion.
  • Have an adequate performance status.
  • Sign an informed consent.

Exclusion Criteria:

  • A female who is pregnant or breastfeeding.
  • Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.
  • Treatment with radiation therapy within the last 1-2 weeks.
  • Brain metastasis that is uncontrolled.
  • Active infection or other serious condition.

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061451
Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.    
      Palo Alto, California, United States
United States, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.    
      Columbia, Missouri, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.    
      Kansas City, Missouri, United States
United States, Montana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.    
      Great Falls, Montana, United States
United States, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.    
      Seattle, Washington, United States

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:

Study ID Numbers:   7213, H3E-US-JMFY
First Received:   May 28, 2003
Last Updated:   January 24, 2007
ClinicalTrials.gov Identifier:   NCT00061451
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
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Therapeutic Uses

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