Octreotide in Treating Patients With Locally Advanced or Metastatic Liver Cancer

What Was Tested

The trial (phase 2) is built around Octreotide.

The registry classes the interventions as drug.

More on the Plan

OBJECTIVES: Primary * To verify that long-acting somatostatin analog octreotide (Sandostatin LAR) depot will extend median survival from 5 months to 8.75 months in patients with locally advanced or metastatic hepatocellular carcinoma with a CLIP score of 3 or more.

Secondary * To document tolerability of this drug in this patient population.

OUTLINE: Patients are stratified according to underlying degree of liver disease as defined by CLIP score classification.

Patients receive short-acting octreotide subcutaneously three times daily on days 1-21 OR days 1-28.

Who Took Part

Enrollment: 31 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: Newly diagnosed or recurrent hepatocellular carcinoma (HCC) as defined by tissue biopsy OR alpha fetoprotein (AFP) \> 1,000 ng/mL with compatible mass on CT scan or MRI. Recurrence of previously resected HCC will not require tissue confirmation if there is clear radiographic recurrence, in the judgment of the investigator. Locally advanced OR metastatic disease. Unmeasurable disease allowed if initial diagnosis was made according to the above criteria and/or recurrence has been confirmed by tissue biopsy or radiological imaging. CLIP score ≥ 3.

The full record lists 25 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Octreotide study did not mask who received what.

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

It started in 2005-07 with completion listed for 2007-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Median survival (time frame: 6 months).

It also tracked 1 secondary outcome, for example number of subjects with toxicities.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 31 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.