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


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

9417

NCT ID:

NCT00191412

Start Date:

January 2005

Completion Date:

March 2006

Related Keywords:

  • Liver Cancer
  • Liver Neoplasms

Name

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 physicianDenver, Colorado