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

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Lilly

Status and phase

Completed
Phase 2

Conditions

Liver Cancer

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191412
H3E-US-S055
9417

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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