Back to resultsALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
Primary Purpose
Metastases, Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALIMTA
folic acid
multi-vitamins
Sponsored by
About this trial
This is an interventional treatment trial for Metastases focused on measuring metastatic cancer, chemotherapy
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic diagnosis of metastatic or locally advanced cancer Prior chemotherapy is allowed Adequate bone marrow, liver and kidney function Exclusion Criteria: Prior treatment with ALIMTA Brain metastasis Pregnancy or breast feeding
Sites / Locations
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00034463
Brief Title
ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
Official Title
A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastases, Cancer
Keywords
metastatic cancer, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ALIMTA
Intervention Type
Drug
Intervention Name(s)
folic acid
Intervention Type
Drug
Intervention Name(s)
multi-vitamins
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic diagnosis of metastatic or locally advanced cancer
Prior chemotherapy is allowed
Adequate bone marrow, liver and kidney function
Exclusion Criteria:
Prior treatment with ALIMTA
Brain metastasis
Pregnancy or breast feeding
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
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