Back to resultsA Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver
Primary Purpose
Liver Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer
Eligibility Criteria
Inclusion Criteria: Diagnosis of cancer of the liver which is metastatic or locally recurrent and not amendable to curative therapy. Patient must have measurable disease Patient may have received prior arterial chemoembolization, completed 8 weeks prior to study enrollment, but no other previous chemotherapy Prior radiation is permitted, but must be completed at least 2 weeks prior to study enrollment. Prior central nervous system metastases are acceptable if the patient has received radiation ot the brain, is not on steroids, and does not have related symptoms. Exclusion Criteria: Patients who have had prior therapy with Pemetrexed. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. Patients who have received radiation to more than 25% of marrow
Sites / Locations
- 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
Outcomes
Primary Outcome Measures
Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors
Secondary Outcome Measures
Toxicity measured by CTCAE grading
Duration of response: First complete or partial response until progressive disease (PD) or death of any cause
Duration of stable disease: Enrollment to PD or death of any cause
Time to treatment failure: Enroll. to PD, death of any cause, early discontinuation of treatment for any reason other than adequate response or start of new therapy
Progression-free survival: Enroll. to PD or death of any cause
Overall survival: Enroll. to death of any cause
Full Information
NCT ID
NCT00191412
First Posted
September 12, 2005
Last Updated
November 19, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00191412
Brief Title
A Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver
Official Title
Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
This study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Primary Outcome Measure Information:
Title
Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors
Secondary Outcome Measure Information:
Title
Toxicity measured by CTCAE grading
Title
Duration of response: First complete or partial response until progressive disease (PD) or death of any cause
Title
Duration of stable disease: Enrollment to PD or death of any cause
Title
Time to treatment failure: Enroll. to PD, death of any cause, early discontinuation of treatment for any reason other than adequate response or start of new therapy
Title
Progression-free survival: Enroll. to PD or death of any cause
Title
Overall survival: Enroll. to death of any cause
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cancer of the liver which is metastatic or locally recurrent and not amendable to curative therapy.
Patient must have measurable disease
Patient may have received prior arterial chemoembolization, completed 8 weeks prior to study enrollment, but no other previous chemotherapy
Prior radiation is permitted, but must be completed at least 2 weeks prior to study enrollment.
Prior central nervous system metastases are acceptable if the patient has received radiation ot the brain, is not on steroids, and does not have related symptoms.
Exclusion Criteria:
Patients who have had prior therapy with Pemetrexed.
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
Patients who have received radiation to more than 25% of marrow
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Denver
State/Province
Colorado
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver
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