A Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver

• ClinicalTrials.gov Identifier: NCT00191412
• Recruitment Status: Completed
• First Posted: September 19, 2005
• Last Update Posted: November 20, 2007
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

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.

Condition or disease	Intervention/treatment	Phase
Liver Cancer	Drug: Pemetrexed	Phase 2

Study Design

• 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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors

Secondary Outcome Measures :

1. Toxicity measured by CTCAE grading
2. Duration of response: First complete or partial response until progressive disease (PD) or death of any cause
3. Duration of stable disease: Enrollment to PD or death of any cause
4. 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
5. Progression-free survival: Enroll. to PD or death of any cause
6. Overall survival: Enroll. to death of any cause

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Lilly Clinical Trial Registry 

• ClinicalTrials.gov Identifier: NCT00191412
• Other Study ID Numbers: 9417; H3E-US-S055
• First Posted: September 19, 2005
• Last Update Posted: November 20, 2007
• Last Verified: November 2007

Additional relevant MeSH terms:

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