Clinical trial NCT01128296 (phase 1/phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: hydroxychloroquine, gemcitabine
SMILES: CCN(CC)CCCC(C)NC1=C2C=CC(Cl)=CC2=NC=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with biopsy-proven adenocarcinoma of the pancreas

          -  staged by IIb or greater by by EUS, or tumor greater than 2.6 cm on EUS or pancreatic
             protocol helical CT scan demonstrating venous involvement

          -  Karnofsky performance status >/= 70.

          -  No active second malignancy except for basal cell carcinoma of the skin

          -  Normal renal, hepatic, and hematologic function at the time of enrollment as evidenced
             by:

               -  Serum creatinine level ≤1.5 the upper limits of normal

               -  Serum total bilirubin level ≤1.5 X ULN

          -  White blood cell count >/= 3.5x109/ml per ml and platelet count ≥ 100x109 per ml

          -  Age >18 years.

          -  For subjects with obstructive jaundice, the biliary tract must be drained with a
             temporary plastic or a short permanent metallic biliary stent.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Subjects deemed surgically unresectable or subjects unwilling to undergo surgical
             resection.

          -  Subjects who have received chemotherapy within 12 months prior to study entry.

          -  Prior use of radiotherapy or investigational agents for pancreatic cancer.

          -  Any evidence of metastasis to distant organs (liver, lung, peritoneum).

          -  Symptomatic or endoscopic evidence of gastric outlet obstruction

          -  Concurrent malignancies with evidence of active or measurable disease except basal
             cell carcinoma of the skin

          -  Inability to adhere to study and/or follow-up procedures

          -  History of allergic reactions or hypersensitivity to the study drugs
             (hydroxychloroquine, gemcitabine).

          -  Other concurrent experimental therapy.

          -  The effects of HCQ, and gemcitabine on the developing human fetus are unknown. For
             this reason women of child-bearing potential and men must agree to use adequate
             contraception (hormonal or barrier method of birth control; abstinence) prior to study
             entry and for the duration of study participation. All females of childbearing
             potential must have a blood test or urine study within two weeks prior to registration
             to rule out pregnancy. Should a woman become pregnant while participating in this
             study, she should inform her treating physician immediately. If a man impregnates a
             woman while participating in this study, he should inform his treating physician
             immediately as well.

          -  Because patients with immune deficiency are at increased risk of lethal infections
             when treated with bone marrow-suppressive therapy, HIV-positive patients are excluded
             from the study. For patients receiving combination anti-retroviral therapy, the
             potential impact of pharmacokinetic interactions with HCQ and gemcitabine is unknown.
             Appropriate studies may be undertaken in patients with HIV and those receiving
             combination anti-retroviral therapy in the future.

          -  Due to the risk of disease exacerbation, patients with porphyria are ineligible.

          -  Patients with psoriasis are ineligible unless the disease is well controlled and they
             are under the care of a specialist who agrees to monitor the patient for
             exacerbations.

          -  Patients requiring the use of enzyme-inducing anti-epileptic medication that includes:
             phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine are excluded.

          -  Patients with previously documented macular degeneration or diabetic retinopathy are
             excluded.

          -  Baseline EKG with QTc >470 msec (including subjects on medication). Subjects with
             ventricular pacemaker for whom QT interval is not measurable will be eligible on a
             case-by-case basis.