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Hepatocellular CarcinomaPhase 2NCT00775073

Antiangiogenic Treatment of Hepatocellular Cancer With Bevacizumab and RAD001

A Phase 2 study testing Everolimus, Bevacizumab in people with Hepatocellular Carcinoma, run by Gerhard Treiber at 10 sites in Germany.

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 is a prospective open label clinical trial in patients with advanced or metastatic liver cancer to assess the clinical and biological activity of RAD001 (Everolimus) in conjunction with Bevazicumab (Avastin). Approximately 36 patients will be enrolled. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Everolimus, Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
10 sitesGermany
Study dates
Oct 2008to Apr 2012
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

  • Age >18 years
  • Patients with non-resectable locally advanced or metastatic hepatocellular cancer BCLC stage B and C. BCLC stage A can occasionally be included provided that other treatment options are unavailable
  • Measurable disease: At least one measurable lesion (longest diameter ≥20 mm on conventional CT or MRI scan; ≥ 10 mm on spiral CT) according to RECIST criteria that has not been previously locally treated by irradiation, surgery, ethanol injection, radiofrequency ablation or transarterial chemoembolisation
  • Confirmation of HCC disease by histology (preceding liver resection or fine needle biopsy within the last 12 months);
  • Liver Function: Child A and B
  • Tumor extent: CLIP Score ≤ 3
  • ECOG Performance Status 0-2 (=Karnofsky-Index ≥ 60%)

Who cannot join

  • Patient had received any prior systemic treatment (possible exception: sorafenib for a maximum of 3 months, last dose received at least 28 days before study inclusion)
  • Patient had a major surgery, local ablative treatments (RFA, PEI), or transarterial chemoembolisation therapy within 4 weeks prior to randomisation
  • Presence of a secondary malignancy either at the time of screening or in the past 5 years: An exception from this rule can be made in patients that were treated in curative intention within the last 3 years and are without any evidence of recurrence of this malignancy.
  • History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis) or other mental illness.
  • Clinically serious infections or uncontrolled infection (including HIV infection), increased risk for acquisition of opportunistic infections
  • Chronic treatment with systemic steroids or another immunosuppressive agent
Show all 22Show fewer
  • Inadequate organ functions, characterised by: cholestasis with elevated levels of bilirubin and/or alkaline phosphatase > 3x UNL (can be improved by biliary drainage if necessary) and/or elevated transaminases (ALAT/ASAT) ≥ 5 x UNL, hypoalbuminemia < 2.5 g/dl, renal impairment (serum creatinine < 1.5 x UNL ), inadequate Hematology: Platelets < 75.000, ANC < 1500, hemoglobin < 9.0 mg/dl, inadequate coagulation status, namely INR > 2 or Quick < 50%, aPTT >50 sec in the absence of any drugs interfering with coagulation such as warfarin, phenprocoumon, NMH or UFH. Fasting serum cholesterol ≤300 mg/dL OR 7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN, patients with severe refractory therapy-resistant hyperlipidemia
  • Women who are pregnant or breast feeding, intended pregnancy, or women unable to conceive and unwilling to practice an effective method of birth control
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of RAD001 and cannot be controlled by adequate medical treatment (e.g. uncontrolled nausea, vomiting, diarrhoea which might result in malabsorption, any known malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets)
  • Mixed tumors of HCC with cholangiocarcinoma or fibrolamellar HCC type
  • Patients with complications of liver cirrhosis such as recent spontaneous bacterial infection of ascites, hepatic encephalopathy > grade 2 during the last 2 weeks and not adequately controlled or hepatorenal syndrome not responding to conservative treatment within 2 weeks
  • Patients with any active gastrointestinal bleeding during the last 2 weeks
  • Patients without screening EGD during the last 2 weeks
  • Patients with nonbleeding gastroesophageal varices grade I° with red coloured signs or grade ≥ II° on EGD that do not undergo prophylactic ligation or sclerosing treatment at least one week before the first dose of study medication is taken.
  • Patients with unhealed gastrointestinal ulcerations or wounds
  • Patients with a history of one of the following: bowel perforation, colon diverticulitis
  • Any relevant findings on screening colonoscopy
  • History of any thromboembolic events (except for portal vein infiltration and/or thrombosis)
  • Allergic reactions or intolerance to previous drug exposure to RAD001 or bevacizumab; having received any of the study medications within the last 3 years before randomisation
  • Allergy or intolerance against CHO-cell products or other recombinant human or humanised antibodies
  • Patients with an increased risk for the development of lymphoma or other malignant diseases, especially concerning the skin
  • Patients with rare hereditary disorders like galactose intolerance, lactase deficiency or glucose-galactose malabsorption

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Zollernalbklinikum

    Balingen, 72336

  • Charité, Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie

    Berlin, 13353

  • Universitaetsklinikum Bonn, Medizinische Klinik und Poliklinik I

    Bonn, 53105

  • Medizinische Klinik 1 University of Erlangen

    Erlangen, Bavaria, 91054

  • Klinikum der J.-W.-Goethe-Universitaet, Medizinische Klinik I

    Frankfurt, 60590

  • Medizinische Universitaetsklinik Freiburg, Innere Medizin II

    Freiburg im Breisgau, 79095

  • Martin-Luther-Universitaet Halle-Wittenberg, Universitaetsklinik und Poliklinik für Innere Medizin I

    Halle, 06120

  • Medizinische Hochschule Hannover, Zentrum Innere Medizin

    Hanover, 30625

  • Universitätsklinikum des Saarlandes Klinik für Innere medizin II

    Homburg/Saar, 66421

  • Medizinische Fakultaet der Otto-von-Guericke-Universitaet, Klinik für Gastroenterologie, Hepatologie und Infektiologie

    Magdeburg, 39120

Other trials in Germany

About this study

Official title: Antiangiogenic Treatment of Advanced or Metastatic Hepatocellular Cancer (HCC) - An Open Label, Stratified, Single-arm Phase II Study of Bevacizumab and RAD001

This is a prospective open label clinical trial in patients with advanced or metastatic liver cancer to assess the clinical and biological activity of RAD001 (Everolimus) in conjunction with Bevazicumab (Avastin). Approximately 36 patients will be enrolled.

Being tested
Everolimus, Bevacizumab
Keywords
Liver cancer, HCC
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

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

  • Everolimus, BevacizumabDrug

    Also called RAD001, Avastin

    Everolimus 5 mg tablet per day orally. Bevazicumab 5 mg per kg intravenous every 2 weeks.

Study groups in NCT00775073
Study groupRoleWhat they receive
TreatmentExperimentalBevacizumab (Avastin) \& Everolimus (RAD001)
Receives: Drug: Everolimus, Bevacizumab

What is being measured

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

  1. Time to Progression

    Measured: 24 and 48 weeks

Secondary outcomes (1)

  1. Overall Survival

    Measured: 24 and 48 weeks

Timeline

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

  1. First posted17 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJan 2011
  4. Study completionApr 2012

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00775073
Sponsor's protocol ID
CRAD001C24100
Status last verified
Apr 2012
First submitted
16 Oct 2008
Last updated
30 Apr 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Treiber G. mTOR inhibitors for hepatocellular cancer: a forward-moving target. Expert Rev Anticancer Ther. 2009 Feb;9(2):247-61. doi: 10.1586/14737140.9.2.247.

    PubMed 19192962

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus, Bevacizumab in people with Hepatocellular Carcinoma, run by Gerhard Treiber at 10 sites in Germany.

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 7 inclusion and 22 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. 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?

Time to Progression (time frame: 24 and 48 weeks). 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 NCT00775073, which also lists 1 linked publication.

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 30 Apr 2012.

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