Pancreatic CancerPhase 1NCT01777477
Adjuvant Effect of Chloroquine on Gemcitabine
A Phase 1 study testing Chloroquine and Gemcitabine in people with Pancreatic Cancer, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Chloroquine and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2012to May 2015
- Phase
- Phase 1
- 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
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Oncology
Zurich, Canton of Zurich, 8091
About this study
Official title: Gemcitabine Combined With Chloroquine in Patients With Metastatic or Unresectable Pancreatic Cancer. A Dose Finding Single Center Phase I Study
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
- Conditions
- Pancreatic Cancer
- Being tested
- Chloroquine, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
Also called Nivaquin
Addition of Chloroquine to Gemcitabine
GemcitabineDrug
Also called Gemzar
| Study group | Role | What they receive |
|---|---|---|
| Chloroquin in addition to Gemcitabine | Experimental | 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. Receives: Drug: Chloroquine; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panagiotis Samaras, MD, Principal investigator, University Hospital Zurich, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777477
- Sponsor's protocol ID
- ONK-USZ-004
- Status last verified
- Sep 2015
- First submitted
- 23 Jan 2013
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine Combined With Chloroquine in Patients With Metastatic or Unresectable Pancreatic Cancer. A Dose Finding Single Center Phase I Study
- ClinicalTrials.gov ID
- NCT01777477
- Acronym / sponsor ID
- ONK-USZ-004
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chloroquin in addition to Gemcitabine | Experimental | Drug: Chloroquine, Drug: GemcitabineGemcitabine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChloroquineAlso: NivaquinAddition of Chloroquine to Gemcitabine | Drug | Chloroquin in addition to Gemcitabine |
| GemcitabineAlso: Gemzar | Drug | Chloroquin in addition to Gemcitabine |
Primary outcome
Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panagiotis Samaras, MD principal investigator
University Hospital Zurich, Department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chloroquine and Gemcitabine in people with Pancreatic Cancer, run by University of Zurich at 1 site in Switzerland.
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 11 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: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2015.