Adjuvant Effect Of Chloroquine On Gemcitabine

Study Overview

Adjuvant Effect of Chloroquine on Gemcitabine

The purpose of this study is to evaluate the safety by defining the maximum tolerated dose (MTD) of Choloroquine when combined with Gemcitabine, and to evaluate preliminary efficacy of combined systemic Gemcitabine and Chloroquine. In addition, the influence of the treatment on the anti-cancer immunity and the value of GOLPH2 as serum marker for pancreatic cancer will be assessed within a translational objective. * Trial with medicinal product

N/A

Pancreatic Cancer

DRUG: Chloroquine
DRUG: Gemcitabine

ONK-USZ-004

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-01-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-09-21
First Submitted that Met QC Criteria 2013-01-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-09-22
First Posted (ESTIMATED) 2013-01-28	Results First Posted N/A	Last Verified 2015-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Chloroquin in addition to Gemcitabine Gemcitabine 1000 mg/m2 i.v. at days 1, 8, 15 of every 28-day cycle. Chloroquine 100 mg, 200 mg or 300 mg (according to dose level) p.o. at days 2, 9, 16 of every 28-day cycle.	DRUG: Chloroquine Addition of Chloroquine to Gemcitabine DRUG: Gemcitabine

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Chloroquin in addition to Gemcitabine

Gemcitabine 1000 mg/m2 i.v. at days 1, 8, 15 of every 28-day cycle. Chloroquine 100 mg, 200 mg or 300 mg (according to dose level) p.o. at days 2, 9, 16 of every 28-day cycle.

DRUG: Chloroquine

Addition of Chloroquine to Gemcitabine

DRUG: Gemcitabine

Primary Outcome Measures	Measure Description	Time Frame
Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine.		8 weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed non-resectable locally advanced or metastatic adenocarcinoma of the pancreas. Assessment is done within 21 days before enrolment.
Age = 18 years
Adequate liver function or kidney function tests, including any of the following: Bilirubin < 2 x ULN, Alanin-Aminotransferase (ALT) < 5 x ULN, Alcaline phosphatase < 5 x ULN, Estimated creatinine clearance > 40 ml/min (using the Cockroft formula)
Adequate haematological values: Haemoglobin > 80 g/L, Leukocytes >3.00 g/L, Neutrophils > 1.00 g/L, Platelets > 100 g/L
Written informed consent
Biliary decompression is mandatory before inclusion into the study in case of bilirubin levels > 50 µmol/L.
Women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during the 12 months thereafter. A negative pregnancy test before inclusion into the trial is required for women of childbearing potential, defined as having not reached the menopause, last menstrual period occurred less than 12 months ago, no surgical sterilization performed, and fallopian tubes and/or uterus have been not surgically removed.
Men who agree not to father a child during participation in the trial or during the 12 months thereafter.

Life expectancy < 3 months
Severe medical or psychiatric co-morbidity prohibiting the planned treatment or the giving of informed consent
Any prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy.
Any prior radiotherapy or combined radio-chemotherapy for pancreatic cancer if completed less than 12 months prior to study inclusion.
Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.
Known glucose-6-phosphate dehydrogenase deficiency.
Concurrent use of other experimental drugs, treatment within a clinical trial within 30 days prior to trial entry.
Active heart disease defined as congestive heart failure > NYHA class 2
Past or current history (within the last 2 years prior to treatment start) of other malignancies except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
Inability or unwillingness to comply with the study protocol
No understanding of the german language

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Panagiotis Samaras, MD, University Hospital Zurich, Department of Oncology

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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