Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma

What Was Tested

The trial (phase 2) is built around Octreotide.

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).

Determine the toxicity of this combination in this population. 2.

Determine the survival of this patient cohort treated with the combination. 3.

It had two arms (groups): Arm 1 (active comparator) and Arm 2 (experimental).

Thalidomide+alpha interferon.

Thalidomide+interferon+Octreotide.

The registry classes the interventions as drug.

More on the Plan

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 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.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 12 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, single-group and open-label.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2000-09 with completion listed for 2006-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma (time frame: Disease progression and toxicity).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.