Adjuvant Effect of Chloroquine on Gemcitabine

Pancreatic Cancer Clinical Trial

Official title:

Gemcitabine Combined With Chloroquine in Patients With Metastatic or Unresectable Pancreatic Cancer. A Dose Finding Single Center Phase I Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777477
• Other study ID #: ONK-USZ-004
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2013
• Last updated: September 21, 2015
• Start date: July 2012
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Chloroquine
Addition of Chloroquine to Gemcitabine
• Gemcitabine

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Department of Oncology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine.		8 weeks	Yes