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CholangiocarcinomaPhase 2NCT01855724

Clinical Trial to Investigate the Efficacy of Treatment With Gemcitabine/Pazopanib in Patients With Biliary Tree Cancer

A Phase 2 study testing Gemcitabine-Pazopanib in people with Cholangiocarcinoma and Gallbladder Carcinoma, run by Hellenic Cooperative Oncology Group at 17 sites in Greece.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether gemcitabine and pazopanib are effective in the treatment of inoperable, locally advanced or metastatic biliary tree cancer (cholangiocarcinoma or gallbladder carcinoma). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Gemcitabine-Pazopanib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
17 sitesGreece
Study dates
28 Jun 2013to 28 Sep 2018
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

  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments,and must be willing to comply with treatment and follow up.
  • Age ≥18 years
  • Histologically confirmed diagnosis of inoperable,locally advanced or metastatic cholangiocarcinoma (adenocarcinoma of intrahepatic,proximal extrahepatic,distal extrahepatic,gallbladder adenocarcinoma and periampullary bile duct adenocarcinoma).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Measurable disease criteria per RECIST v1.1.
  • No prior chemotherapy or treatment with targeted therapy
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  • Formalin-fixed paraffin-embedded tumour and whole blood/plasma samples at diagnosis/study enrollment for biomarker studies.
  • Adequate organ system function as specified in the protocol
  • Female patients are allowed to participate provided they consent to avoid pregnancy throughout the course of the trial and 1 month after the last administration of the drug, if they are surgically sterilized or menopausal.

Who cannot join

  • Prior malignancy.Subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma or indolent prostate cancer are eligible (even if they are receiving antihormonal therapy).
  • Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases are asymptomatic and have no requirement for steroids or enzyme-inducing anticonvulsants in the past 6 months.
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal, 28 days prior to study treatment initiation.
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including malabsorption syndrome, major resection of the stomach
  • Corrected QT interval (QTc) >480 milliseconds using Bazett's formula
  • History of myocardial infarction, unstable angina, symptomatic peripheral vascular disease or Class II,III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) or cardiac angioplasty or stenting within the past 6 months
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  • Newly-diagnosed hypertension or history of poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 millimeters of mercury (mmHg)or diastolic blood pressure (DBP) of ≥90mmHg].
  • History of cerebrovascular accident including transient ischemic attack(TIA),pulmonary embolism or untreated deep venous thrombosis(DVT) within the past 6 months.Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
  • Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture,or ulcer (procedures such as catheter placement not considered to be major).
  • Evidence of active bleeding or bleeding diathesis.
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage
  • Recent hemoptysis (≥ ½ teaspoon of red blood within 8 weeks of first dose of study drug).
  • Any serious and/or unstable pre-existing medical,psychiatric, or other condition that could interfere with subject's safety,provision of informed consent,or compliance to study procedures.
  • Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug(whichever is longer) prior to the first dose of study drug and for the duration of the study
  • Radiation therapy,surgery or tumor embolization within 14 days prior to the first dose of pazopanib
  • Administration of any non-oncologic investigational study drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment.
  • Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
  • Pregnancy or lactation.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Greece17 sites

  • 2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital

    Athens, 11522

  • Dept of Medical Oncology, 251 General Air Force Hospital

    Athens, 11525

  • 2nd Dept of Internal Medicine, General Hospital of Athens "Hippokratio"

    Athens, 11527

  • Oncology Dept, 2nd Surgyc Clinic, Aretaieio Hospital

    Athens, 11528

  • Oncology Section, Dept of Clinical Therapeutics, General Hospital of Athens "Alexandra"

    Athens, 11528

  • Division of Oncology, 2nd Dept of Internal Medicine, Propaedeutic, University Hospital "Attikon"

    Athens, 12462

  • 2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

    Athens, 14564

  • 3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

    Athens, 14564

  • 3rd Dept of Medical Oncology, Hygeia Hospital

    Athens, 15123

  • 1st Dept of Medical Oncology, Metropolitan Hospital

    Athens, 18547

  • 2nd Dept of Medical Oncology, Metropolitan Hospital

    Athens, 18547

  • Dept of Medical Oncology, University Hospital of Heraklion

    Heraklion, 71110

  • Dept of Medical Oncology, Ioannina University Hospital

    Ioannina, 45500

  • Division of Oncology, Dept of Internal Medicine, University Hospital of Patras

    Pátrai, 26504

  • 2nd Dept of Medical Oncology, EUROMEDICA General Clinic of Thessaloniki

    Thessaloniki, 54645

  • Dept of Medical Oncology, Papageorgiou General Hospital

    Thessaloniki, 56429

  • Dept of Medical Oncology, Thermi Clinic S.A

    Thessaloniki, 57001

Other trials in Greece

About this study

Official title: Phase II Single-arm Study of First Line Treatment With Gemcitabine and Pazopanib in Patients With Inoperable Locally Advanced or Metastatic Biliary Tree Cancer (Cholangiocarcinoma or Gallbladder Carcinoma)

The purpose of this study is to determine whether gemcitabine and pazopanib are effective in the treatment of inoperable, locally advanced or metastatic biliary tree cancer (cholangiocarcinoma or gallbladder carcinoma).

Read the detailed description

This is an open label, uncontrolled, multicenter, phase II study to evaluate the efficacy and safety of Gemcitabine/Pazopanib combination as 1st line treatment in patients with unresectable, locally advanced or metastatic biliary tree adenocarcinoma. A total of 46 patients will be included in the study. The patients will receive open label Gemcitabine 1000 mg/m2 intravenously on days 1 and 8 and Pazopanib 800 mg per os on days 1 to 21 every 21 days. Treatment with gemcitabine/pazopanib combination will continue until disease progression, appearance of significant toxicity, completion of 8 cycles or informed consent withdrawal. Upon completion of 8 treatment cycles with the combination, and in the absence of disease progression, administration of pazopanib monotherapy as maintenance treatment will be continued until disease progression, appearance of significant toxicity or informed consent withdrawal.

Imaging assessments will be performed every 8 weeks

Being tested
Gemcitabine-Pazopanib
Medical subject headings
Cholangiocarcinoma, Gallbladder Neoplasms

What participants receive

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

  • Gemcitabine-PazopanibDrug

    Also called Gemzar, Votrient

Study groups in NCT01855724
Study groupRoleWhat they receive
Gemcitabine-PazopanibExperimentalGemcitabine 1000 mg/m2 administered intravenously on days 1 and 8 and Pazopanib 800 mg administered per os on days 1 to 21 every 21 days. Treatment with gemcitabine/pazopanib combination will continue until disease progression, appearance of significant toxicity, completion of 8 cycles or informed consent withdrawal. Upon completion of 8 treatment cycles with the combination, and in the absence of disease progression, administration of pazopanib monotherapy as maintenance treatment will be continued until disease progression, appearance of significant toxicity or informed consent withdrawal.
Receives: Drug: Gemcitabine-Pazopanib

What is being measured

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

  1. Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Imaging evaluation for the determination of response to treatment will be performed every 8 weeks

    Measured: At an average of 6 months for each patient

Secondary outcomes (6)

  1. Evaluation of Progression-Free Survival (PFS)

    Measured: PFS will be calculated from the date of treatment initiation to the date of disease progression or date of death, assessed up to 48 months

  2. Evaluation of 6-month Progression-Free Survival rate (6-month PFS rate)

    The aim is to determine the rate of PFS in patients, at 6 months of treatment

    Measured: Assessed up to 6 months

  3. Evaluation of Overall Survival (OS)

    Measured: OS will be calculated from the date of treatment initiation to the date of death from any cause, assessed up to 48 months.

  4. Assessment of safety and tolerability

    Distribution of Adverse Events (AEs) according to severity grade. Evaluation of AEs will be performed every 21 days (per treatment cycle) throughout the course of treatment

    Measured: Assessed up to 48 months

  5. Evaluation of Quality of Life (QoL)

    Quality of Life Questionnaires will be filled out before treatment initiation, every 8 weeks and at the end of treatment

    Measured: Assessed up to 9 months

  6. Evaluation of potential prognostic and/or predictive biomarkers in tissue and blood samples

    The following biomarkers will be analyzed:

    In bioptic material:

    • Stem Cell Factor (KIT)
    • Vascular Endothelial Growth Factor Receptor-2 (VEGF-2)
    • Vascular Endothelial Growth Factor Receptor-3 (VEGF-3)

    In peripheral blood/plasma:

    • Interleukin 8
    • Interleukin 12
    • Hepatocyte growth factor

    There may be additions to the biomarkers to be analyzed, dependent on the clinical and bibliographical data

    Measured: Tumor blocks and blood samples will be collected at baseline

Timeline

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

  1. First posted16 May 2013 (estimated)
  2. Study start28 Jun 2013
  3. Primary completion15 Sep 2018
  4. Study completion28 Sep 2018

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01855724
Sponsor's protocol ID
HE 37/12
Other IDs
2012-001705-24
Status last verified
Sep 2017
First submitted
14 May 2013
Last updated
7 Nov 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine-Pazopanib in people with Cholangiocarcinoma and Gallbladder Carcinoma, run by Hellenic Cooperative Oncology Group at 17 sites in Greece.

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 9 inclusion and 18 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: stopped early, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Greece. 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 was stopped early. Results are not available in the source record.

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?

Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (time frame: At an average of 6 months for each patient). 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 NCT01855724.

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 7 Nov 2018.

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