Liver Cancer
Conditions
Brief summary
This study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.
Interventions
DRUGPemetrexed
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Toxicity measured by CTCAE grading | — |
| Progression-free survival: Enroll. to PD or death of any cause | — |
| Overall survival: Enroll. to 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 | — |
Countries
United States
Outcome results
None listed