A Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00191412 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : November 20, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Cancer | Drug: Pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 41 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma |
Study Start Date : | January 2005 |
Actual Study Completion Date : | March 2006 |

- Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors
- 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

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

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): NCT00191412
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 |
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 |
ClinicalTrials.gov Identifier: | NCT00191412 |
Other Study ID Numbers: |
9417 H3E-US-S055 |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | November 20, 2007 |
Last Verified: | November 2007 |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases |
Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |