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

NCT01855724 | Terminated Phase 2

• 2 other identifiers: HE 37/122012-001705-24
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 17

Brief 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).

Conditions

Cholangiocarcinoma; Gallbladder Carcinoma; Biliary Carcinoma

Outcome Measures

Primary Outcomes (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

  At an average of 6 months for each patient

Secondary Outcomes (6)

• Evaluation of Progression-Free Survival (PFS)

  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

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

  Assessed up to 6 months

• Evaluation of Overall Survival (OS)

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

• Assessment of safety and tolerability

  Assessed up to 48 months

• Evaluation of Quality of Life (QoL)

  Assessed up to 9 months

Study Arms (1)

Gemcitabine-Pazopanib

EXPERIMENTAL

Gemcitabine 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.

Drug: Gemcitabine-Pazopanib

Interventions

Gemcitabine-Pazopanib DRUG

Also known as: Gemzar, Votrient

Gemcitabine-Pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead
• GlaxoSmithKline: collaborator

Study Sites (17)

2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital

Athens, 11522, Greece

Location

Dept of Medical Oncology, 251 General Air Force Hospital

Athens, 11525, Greece

Location

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

Athens, 11527, Greece

Location

Oncology Dept, 2nd Surgyc Clinic, Aretaieio Hospital

Athens, 11528, Greece

Location

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

Athens, 11528, Greece

Location

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

Athens, 12462, Greece

Location

2nd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

Athens, 14564, Greece

Location

3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

Athens, 14564, Greece

Location

3rd Dept of Medical Oncology, Hygeia Hospital

Athens, 15123, Greece

Location

1st Dept of Medical Oncology, Metropolitan Hospital

Athens, 18547, Greece

Location

2nd Dept of Medical Oncology, Metropolitan Hospital

Athens, 18547, Greece

Location

Dept of Medical Oncology, University Hospital of Heraklion

Heraklion, 71110, Greece

Location

Dept of Medical Oncology, Ioannina University Hospital

Ioannina, 45500, Greece

Location

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

Pátrai, 26504, Greece

Location

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

Thessaloniki, 54645, Greece

Location

Dept of Medical Oncology, Papageorgiou General Hospital

Thessaloniki, 56429, Greece

Location

Dept of Medical Oncology, Thermi Clinic S.A

Thessaloniki, 57001, Greece

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Gallbladder Neoplasms

Interventions

Gemcitabine; pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Joseph Sgouros, MD

  3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 16, 2013
• Study Start: June 28, 2013
• Primary Completion: September 15, 2018
• Study Completion: September 28, 2018
• Last Updated: November 7, 2018

Record last verified: 2017-09

Locations

GR (17)