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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)

Phase 2
18 Years
Open (Enrolling)
Cholangiocarcinoma, Gallbladder Carcinoma, Biliary Carcinoma

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Trial Information

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)

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

Inclusion Criteria:

- 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

- 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.

Exclusion Criteria:

- 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

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

At an average of 6 months for each patient

Safety Issue:


Principal Investigator

Joseph Sgouros, MD

Investigator Role:

Study Chair

Investigator Affiliation:

3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital


Greece:National Organization for Medicines

Study ID:

HE 37/12



Start Date:

June 2013

Completion Date:

November 2016

Related Keywords:

  • Cholangiocarcinoma
  • Gallbladder Carcinoma
  • Biliary Carcinoma
  • Carcinoma
  • Cholangiocarcinoma
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms