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Adjuvant Effect of Chloroquine on Gemcitabine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777477
First Posted: January 28, 2013
Last Update Posted: September 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose

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

Condition Intervention Phase
Pancreatic Cancer Drug: Chloroquine Drug: Gemcitabine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine Combined With Chloroquine in Patients With Metastatic or Unresectable Pancreatic Cancer. A Dose Finding Single Center Phase I Study

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine. [ Time Frame: 8 weeks ]

Enrollment: 9
Study Start Date: July 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Nivaquin
Drug: Gemcitabine
Other Name: Gemzar

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777477


Locations
Switzerland
University Hospital Zurich, Department of Oncology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Panagiotis Samaras, MD University Hospital Zurich, Department of Oncology
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01777477     History of Changes
Other Study ID Numbers: ONK-USZ-004
First Submitted: January 23, 2013
First Posted: January 28, 2013
Last Update Posted: September 22, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Chloroquine diphosphate
Chloroquine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents