Cancer of Liver
Conditions
Keywords
Liver cancer
Brief summary
Our long-term working hypothesis is that if 3-D radiation is combined with the effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. The primary objective is to determine the maximum tolerated dose of capecitabine used along with 3-D conformal radiation therapy. Capecitabine will be taken by mouth each day of radiation. The total daily dose should be taken as two divided doses approximately 12 hours apart, within 30 minutes after eating, ideally after breakfast and the evening meal. The overall total number of patients expected to participate in this study could be as high as 30 depending on how the treatment is tolerated. The first group (3-6 patients) on the study will receive the drug (Xeloda®) at 600mg/m² (level 1) and radiation. If the first group does well, the second group of patients on the study (3-6 patients) will receive 825 mg/m² (level 2) and radiation. If the second group does well, the third group will receive 1,000 mg/m² (level 3) and radiation. If the first dose level of 600mg/m² is NOT tolerated, we will reduce the dose to 500mg/m² and enroll another 3-6 patients at the lower dose. After the highest tolerated dose is identified, 12 additional patients will be treated at that dose to further test the safety of the treatment and better understand the effects of the treatment on disease with more patients. The following tests and procedures are part of regular medical treatment (standard care) for the disease and are also required for this study. * physical examinations * blood tests including pregnancy test * urinalysis * ECG (heart tracing) * chest X-ray * CT scan of the abdomen Follow-up visits are done 1 month after radiation, then 3 months later, then every 3 months for 2 years.
Interventions
Sponsors
Hoffmann-La Roche
James A. Haley Veterans Administration Hospital
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
* Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. * Age \>18 years * Ambulatory outpatients (if applicable), with Karnofsky performance status of \>60 * Histologically or cytologically confirmed unresectable hepatocellular carcinoma, liver mets with no evidence of extrahepatic disease, or cholangiocarcinoma. (see
Exclusion criteria
10) * At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques. * Protocol Specific Laboratory Values as described below in section 6.9 number15. * Has a negative serum pregnancy test within 7 days prior to start of therapy (female patients of childbearing potential). * Have concomitant medications been reviewed with patient to address contraindicated medications described in protocol section 6.2.8 and have precautions been taken as recommended for each drug? Includes Allopurinol, Cimetidine, Sorivudine and Brivudine, Anticoagulants, Phenytoin, and Laxatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity. | — |
Countries
United States
Outcome results
None listed