A Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191412

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 II

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Pemetrexed disodium Pemetrexed

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

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

Contacts and Locations

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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	9417, H3E-US-S055
Study First Received:	September 12, 2005
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00191412
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Liver Neoplasms
Liver Diseases
Digestive System Diseases

Digestive System Neoplasms
Liver neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Hepatocellular carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009