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Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00330044
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : December 2, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Description
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Brief Summary:
To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer

Condition or disease Intervention/treatment Phase
Inoperable Non Small Cell Lung Cancer Drug: Premetrexed (Alimta) Drug: Carboplatin Phase 1

Detailed Description:

To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy.

To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Premetrexed (Alimta) and Carboplatin and Radiation Therapy in Patients With Inoperable Non Small Cell Lung Cancer.
Study Start Date : April 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Drug
Carboplatin and Pemetrexed
 Drug: Premetrexed (Alimta)
Drug: Carboplatin


Outcome Measures
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Primary Outcome Measures :
  1. Response and Progression Free Survival [ Time Frame: Up to five years after study completion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions

Exclusion Criteria:

  • Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330044


Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Eli Lilly and Company
Investigators
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Principal Investigator: Maria Werner-Wasik, MD Thomas Jefferson University
More Information
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Additional Information:

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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00330044    
Other Study ID Numbers: 05C.276
2005-19 ( Other Identifier: CCRRC )
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Antineoplastic Agents