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

Liver Cancer Clinical Trial

Official title:

Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191412
• Other study ID #: 9417
• Secondary ID: H3E-US-S055
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: November 19, 2007
• Start date: January 2005
• Est. completion date: March 2006

Study information

• Verified date: November 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cancer

Intervention

Drug:
• Pemetrexed

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors
Secondary	Toxicity measured by CTCAE grading
Secondary	Duration of response: First complete or partial response until progressive disease (PD) or death of any cause
Secondary	Duration of stable disease: Enrollment to PD or death of any cause
Secondary	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
Secondary	Progression-free survival: Enroll. to PD or death of any cause
Secondary	Overall survival: Enroll. to death of any cause

External Links

•   Lilly Clinical Trial Registry