Adjuvant Effect of Chloroquine on Gemcitabine

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01777477
First received: January 23, 2013
Last updated: January 28, 2013
Last verified: January 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777477

Contacts
Contact: Panagiotis Samaras, MD panagiotis.samaras@usz.ch

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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01777477     History of Changes
Other Study ID Numbers: ONK-USZ-004
Study First Received: January 23, 2013
Last Updated: January 28, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Chloroquine
Chloroquine diphosphate
Gemcitabine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 18, 2014