Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
Completed · Phase 2
Conditions studied: Liver, Cancer
In brief
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.
Key facts
- Study ID
- NCT00250796
- Run by
- University of New Mexico
- People needed
- 12
- Starts
- 2000-09-01
- Expected to finish
- 2006-03-01
- Last updated by the study team
- 2010-01-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein >500 ng/ ml
- The tumor is unresectable
- Performance status of < 2.0
- > 18 years of age
- Informed consent to be signed by patient
- No previous treatment with thalidomide, alpha interferon, or octreotide
- The patient may have received previous chemotherapy either systemically or via the intra hepatic artery.
- The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation.
- The patient must have measurable disease.
- If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy.
- Bilirubin <3 X ULN, AST/ALT<3 X ULN, creat<2, ANC>1.5, Platelet>75K
- Patients may not have symptomatic cholelithiasis.
Where it is running
- University of New Mexico — Albuquerque, New Mexico, United States
- New Mexico Cancer Care Associates — Santa Fe, New Mexico, United States
Full record on ClinicalTrials.gov
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