Gemcitabine Combined With Chloroquine in Patients With Metastatic or Unresectable Pancreatic Cancer. A Dose Finding Single Center Phase I Study
- Histologically or cytologically confirmed non-resectable locally advanced or
metastatic adenocarcinoma of the pancreas. Assessment is done within 21 days before
- 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
- 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