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CompletedNCT00191412Updated Nov 20, 2007

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

A Phase 2 interventional study of Pemetrexed in Liver Cancer, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-20.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Liver Cancer

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03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 41 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants

Interventions

  • DrugPemetrexed
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  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

07

Study locations

1 site
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00191412
Lead sponsor
Eli Lilly and Company
First posted
Sep 19, 2005
Start date
Jan 2005
Completion
Mar 2006
Last update
Nov 20, 2007

Study contacts

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)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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