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

NCT00191412 | Completed Phase 2

• 2 other identifiers: 9417H3E-US-S055
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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

Interventions

Pemetrexed DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: January 1, 2005
• Study Completion: March 1, 2006
• Last Updated: November 20, 2007

Record last verified: 2007-11

Locations

US (1)