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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191412
First received: September 12, 2005
Last updated: November 19, 2007
Last verified: November 2007
  Purpose

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


Condition Intervention Phase
Liver Cancer
Drug: Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors

Secondary Outcome Measures:
  • 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
  • Overall survival: Enroll. to death of any cause

Estimated Enrollment: 41
Study Start Date: January 2005
Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191412

Locations
United States, Colorado
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00191412     History of Changes
Other Study ID Numbers: 9417, H3E-US-S055
Study First Received: September 12, 2005
Last Updated: November 19, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 23, 2014