A Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191412
First received: September 12, 2005
Last updated: November 19, 2007
Last verified: November 2007
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Purpose
This study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: Pemetrexed |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
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
| Estimated Enrollment: | 41 |
| Study Start Date: | January 2005 |
| Study Completion Date: | March 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191412
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191412
Locations
| United States, Colorado | |
| 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 | |
| Denver, Colorado, 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00191412 History of Changes |
| Other Study ID Numbers: | 9417, H3E-US-S055 |
| Study First Received: | September 12, 2005 |
| Last Updated: | November 19, 2007 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on March 03, 2015