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Adult Primary Hepatocellular CarcinomaPhase 2NCT00077441

Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)

A Phase 2 study testing bortezomib and laboratory biomarker analysis in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well bortezomib works in treating patients with hepatocellular carcinoma (liver cancer) that cannot be removed with surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
Apr 2005to Jun 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed hepatocellular carcinoma (HCC) that is not amenable to surgical resection
  • Must have measurable disease; NOTE: For patients having only lesions measuring > 1 cm to =< 2 cm must use spiral CT imaging for all tumor assessments
  • Absolute neutrophil count (ANC) >= 1500/mm^3
  • PLT >= 75,000/mm^3
  • Total bilirubin =< 3 x upper normal limit (UNL)
  • Serum AST =< 5 x UNL
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  • Serum ALT =< 5 x UNL
  • Serum creatinine =< 2 mg/dL
  • Serum albumin >= 2.5 g/dL
  • PT/ INR =< 1.5 (EXCEPTION - Patients with full-dose anticoagulants are eligible provided the patient has been on a stable dose, >= 2 weeks, of warfarin or low molecular weight heparin and has an PT/INR range 2-3)
  • Child-Pugh classification of A or B
  • Patients may not have received prior systemic chemotherapy BUT may have received prior chemoembolization, cryotherapy, radiofrequency ablation, ethanol injection, or photodynamic therapy, provided the following criteria are met:
  • > 6 weeks has elapsed since that therapy
  • Indicator lesion(s) is/are outside the area of prior treatment or, if the only indicator lesion is inside the prior treatment area, there must be clear evidence of disease progression associated with that lesion
  • Edges of the indicator lesion are clearly distinct on CT scanning
  • ECOG performance status (PS) 0, 1, or 2
  • Estimated life expectancy >= 24 weeks
  • Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide written informed consent

Who cannot join

  • Any of the following:
  • Prior systemic anticancer therapy. Note: Chemoembolization is allowed and for trial purposes is not considered a systemic chemotherapy; however, >= 6 weeks must have elapsed between chemoembolization and enrollment on this study
  • Prior PS-341 therapy
  • Immunotherapy =< 4 weeks have elapsed prior to study entry
  • Biologic therapy =< 4 weeks have elapsed prior to study entry
  • Radiation therapy =< 4 weeks have elapsed prior to study entry
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  • Cryotherapy =< 6 weeks have elapsed since prior to study entry
  • Radiofrequency ablation =< 6 weeks have elapsed since prior to study entry
  • Ethanol injection =< 6 weeks have elapsed since prior to study entry
  • Photodynamic therapy =< 6 weeks have elapsed since prior to study entry
  • Major surgery, or significant traumatic injury =< 3 weeks prior to study entry
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
  • Presence of > grade 1 sensory peripheral neuropathy of any etiology OR grade 1 with neuropathic pain of any etiology
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PS-341
  • History of other malignancy =< 3 years prior to study entry, except for adequately treated basal cell or squamous cell skin cancer
  • Any of the following as this regimen may be harmful to a developing fetus or nursing child:
  • Pregnant women
  • Breastfeeding women
  • Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
  • Known CNS metastases
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris, cardiac arrhythmia
  • Psychiatric illness that would limit compliance with study requirements
  • HIV-positive patients receiving combination anti-retroviral therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase II Trial of PS-341 in Patients With Hepatocellular Carcinoma

This phase II trial is studying how well bortezomib works in treating patients with hepatocellular carcinoma (liver cancer) that cannot be removed with surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Proportion of confirmed tumor responses.

SECONDARY OBJECTIVES:

  1. To evaluate the confirmed and objective response rate. II. To assess patient outcome as estimated by duration of response, time to disease progression, and survival.

III. To evaluate the adverse event rates associated with PS-341 in this population.

IV. To explore the relationships between laboratory correlates (eg. IHC) and patient outcome (eg p53 and disease progression).

  1. To evaluate alterations in laboratory correlates from pre-treatment measurements (ie, pre and post treatment). The following immunohistochemistry (IHC) assays will be performed: IHC of p53, IHC of p21, IHC of p27, IHC of NFkB, IHC of Ki67.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry.

Being tested
bortezomib, laboratory biomarker analysis
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bortezomibDrug

    Also called LDP 341, MLN341, VELCADE

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00077441
Study groupRoleWhat they receive
Treatment (bortezomib)ExperimentalPatients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: bortezomib; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart

    Ninety-five percent confidence intervals for the true success proportion will be calculated.

    Measured: Up to 36 weeks (12 courses)

Secondary outcomes (4)

  1. Survival time

    The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to death due to any cause, assessed up to 3 years

  2. Time to disease progression

    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to documentation of disease progression, assessed up to 3 years

  3. Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented

    Measured: Up to 3 years

  4. Time to treatment failure

    Measured: Time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2004 (estimated)
  2. Study startApr 2005
  3. Primary completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077441
Sponsor's protocol ID
NCI-2012-02806
Other IDs
MC0255, N01CM62205
Status last verified
Jun 2013
First submitted
10 Feb 2004
Last updated
4 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib and laboratory biomarker analysis in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart (time frame: Up to 36 weeks (12 courses)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00077441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013.

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