Adjuvant Effect of Chloroquine on Gemcitabine
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Chloroquine
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion criteria:
- 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.
Patient compliance and geographic proximity allow proper staging and follow-up. Patient not eligible for FOLFIRINOX treatment. WHO PS 0-2
Exclusion criteria:
- 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
Sites / Locations
- University Hospital Zurich, Department of Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chloroquin in addition to Gemcitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine.
Secondary Outcome Measures
Full Information
NCT ID
NCT01777477
First Posted
January 23, 2013
Last Updated
September 21, 2015
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT01777477
Brief Title
Adjuvant Effect of Chloroquine on Gemcitabine
Official Title
Gemcitabine Combined With Chloroquine in Patients With Metastatic or Unresectable Pancreatic Cancer. A Dose Finding Single Center Phase I Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chloroquin in addition to Gemcitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Other Intervention Name(s)
Nivaquin
Intervention Description
Addition of Chloroquine to Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Patient compliance and geographic proximity allow proper staging and follow-up. Patient not eligible for FOLFIRINOX treatment. WHO PS 0-2
Exclusion criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiotis Samaras, MD
Organizational Affiliation
University Hospital Zurich, Department of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Department of Oncology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Effect of Chloroquine on Gemcitabine
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