Adjuvant Effect of Chloroquine on Gemcitabine

Condition(s) targeted: Pancreatic Cancer

Intervention: Chloroquine (Drug); Gemcitabine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Zurich

Official(s) and/or principal investigator(s):
Panagiotis Samaras, MD, Principal Investigator, Affiliation: University Hospital Zurich, Department of Oncology

Overall contact:
Panagiotis Samaras, MD, Email: panagiotis.samaras@usz.ch

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

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

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

Primary outcome: Maximum tolerated dose (MTD) of orally administered Chloroquine with concomitant intravenous Gemcitabine.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Panagiotis Samaras, MD, Email: panagiotis.samaras@usz.ch

University Hospital Zurich, Department of Oncology, Zurich, ZH 8091, Switzerland; Recruiting

Starting date: July 2012
Last updated: January 28, 2013