Cancer, Liver
Conditions
Keywords
Phase II, Hepatocellular carcinoma
Brief summary
Primary Aim Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma (cancer of the liver that can't be treated surgically). Secondary Aims 1. Determine the toxicity of this combination in this population. 2. Determine the survival of this patient cohort treated with the combination. 3. Determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan.
Detailed description
The purpose of this study is to determine the response rate and time to progression of the combination of thalidomide, alfa interferon, and octreotide (Sandostatin LAR) in patients with unresectable hepatocellular carcinoma. If patients are eligible for and agree to take part in the study, they will be assigned to one of two treatment arms depending on SSR status. If SSR status is positive or unknown, patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance. They will also receive injections three times a week of alpha interferon and monthly injections of octreotide (Sandostatin LAR) 30 mg into their buttocks muscle.. If the patient SSR status is negative, patients will not be given subcutaneous injections of octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.
Interventions
DRUGThalidomide, alpha interferon
If the patient SSR status is negative, patients will not be given subcutaneous injections of octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.
DRUGThalidomide, interferon, Octreotide
If SSR status is positive or unknown, patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance. They will also receive injections three times a week of alpha interferon and monthly injections of octreotide (Sandostatin LAR) 30 mg into their buttocks muscle..
Sponsors
University of New Mexico
Study design
Allocation
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
1. Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein \>500 ng/ ml 2. The tumor is unresectable 3. Performance status of \< 2.0 4. \> 18 years of age 5. Informed consent to be signed by patient 6. No previous treatment with thalidomide, alpha interferon, or octreotide 7. The patient may have received previous chemotherapy either systemically or via the intra hepatic artery. 8. The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation. 9. The patient must have measurable disease. 10. If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy. 11. Bilirubin \<3 X ULN, AST/ALT\<3 X ULN, creat\<2, ANC\>1.5, Platelet\>75K 12. Patients may not have symptomatic cholelithiasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma. | Disease progression and toxicity |
Countries
United States
Outcome results
None listed