Clinical trial NCT02767752 (phase 2, status: terminated)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: gemcitabine, capecitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    poor accrual and change of soc (folfirinox in adjuvant setting)
  
Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent

          2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic
             complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors
             are excluded

          3. Subject should be able to start treatment no later than 12 weeks post-surgery

          4. Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of
             signing the informed consent form (ICF)

          5. ECOG/WHO Performance Status (PS) 0-1

          6. Females of child-bearing potential (defined as a sexually mature woman who (1) has not
             undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy
             [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal
             for at least 24 consecutive months [i.e., has had menses at any time during the
             preceding 24 consecutive months]) must:

               -  Agree to the use of two physician-approved contraceptive methods (oral,
                  injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine
                  device; barrier contraceptive with spermicide; or vasectomized partner) while on
                  study IP; and for 3months following the last dose of IP

               -  Has negative serum pregnancy test (β-hCG) result at screening

          7. Male subjects:

             • Must practice true abstinence or agree to use a condom during sexual contact with a
             pregnant female or a female of childbearing potential while participating in the
             study, during dose interruptions and for 6 months following IP discontinuation, even
             if he has undergone a successful vasectomy

          8. Understand and voluntarily sign an ICF prior to any study related assessments or
             procedures being conducted

          9. Be able to adhere to the study visit schedule and other protocol requirements

         10. Acceptable hematology parameters defined as:

               -  Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L

               -  Platelet count ≥ 100 x 10⁹/L

               -  Haemoglobin ≥ 5.6 mmol/L

         11. Acceptable liver function defined as:

               -  Serum bilirubin < 1.5 x upper limit of normal (ULN)

               -  ASAT/ALAT < 2.5 x ULN

         12. Acceptable renal function with a creatinine clearance ≥ 50 mL/min/ (e.g., using the
             Cockroft-Gault formula)

        Exclusion Criteria:

          1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic
             adenocarcinoma

          2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma

          3. Other malignancies, except adequately treated basal carcinoma or squamous cell
             carcinoma of the skin or in situ cervix carcinoma or incidental prostate cancer (T1a,
             Gleason score ≤ 6, PSA < 0.5 ng/ml), or any other tumor with a DSF survival of ≥ 5
             years

          4. History of serious or concurrent illness or uncontrolled medical disorder; any medical
             condition that might be aggravated by chemotherapy treatment or which could not be
             controlled; including, but not restricted to:

               -  Active infection requiring antibiotics within 2 weeks before the study inclusion

               -  Concurrent congestive heart failure NYHA class III - IV

               -  Unstable angina pectoris, or myocardial infarction within 6 months and/or prior
                  poorly controlled hypertension

               -  History of interstitial lung disease, slowly progressive dyspnea and unproductive
                  cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary
                  hypersensitivity pneumonitis or multiple allergies

               -  Concomitant use of immunosuppressive or myelosuppressive medications that would
                  in the opinion of the investigator, increase the risk of serious neutropenic
                  complications

          5. Known or suspected allergy to the investigational agents or any agents given in
             association with this trial

          6. Any psychological, familial, sociological, or geographical condition which does not
             permit protocol compliance and medical follow-up

          7. Enrollment in any other clinical protocol or investigational study with an
             interventional agent or assessments that may interfere with study procedures

          8. Any condition including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study

          9. Any condition that confounds the ability to interpret data from the study

         10. Unwillingness or inability to comply with study procedures

         11. Current use of anticoagulation therapy such as heparins both unfractionated and low
             molecular weighted