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OpenTrials
Completed

NCT Number: NCT00191412

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

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

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Nov 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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