Clinical trial NCT00398086 (phase 1/phase 2, status: completed)
Conditions: metastatic pancreatic cancer
ICD codes: C25.3
Drugs: gemcitabine, albumin-bound paclitaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C
Eligibility criteria:

        Inclusion Criteria:

          -  Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the
             pancreas. Patients with islet cell neoplasms are excluded.

          -  Male or non-pregnant and non-lactating female, and age greater or equal to 18.

               -  If a female patient is of child-bearing potential, as evidenced by regular
                  menstrual periods, she must have a negative serum pregnancy test beta-human
                  chorionic gonadotropin (B-hCG) documented within 72 hours of the first
                  administration of study drug.

               -  If sexually active, the patient must agree to use contraception considered
                  adequate and appropriate by the investigator.

          -  Patient must have received no prior therapy for the treatment of metastatic disease.
             Prior treatment with 5-fluorouracil (5-FU) or gemcitabine administered as a radiation
             sensitizer during and up to 4 weeks after radiation therapy is allowed. If a patient
             received gemcitabine in the adjuvant setting, tumor recurrence must have occurred at
             least 6 months after completing the last dose of gemcitabine.

          -  Patient has the following blood counts at baseline

               -  Absolute neutrophil count (ANC) equal or greater to 1.5 x 10^9/L;

               -  Platelets equal or greater to 100 x 10^9/L

               -  Hemoglobin equal or greater to 9 g/dL.

               -  Patient has the following blood chemistry levels at baseline:

               -  Aspartate aminotransferase (SGOT), Alanine aminotransferase (SGPT) equal or less
                  than 2.5 x upper limit of normal range (ULN) is allowed

               -  Bilirubin less than or equal to ULN

               -  Serum creatinine within normal limits or calculated clearance equal or greater to
                  60 mL/min/1.73M^2 patients with serum creatinine levels above the institutional
                  normal value

          -  Patient has no clinically significant abnormalities in urinalysis results

          -  Patient has acceptable coagulation status as indicated by a prothrombin time (PT)
             within normal limits (plus or minus 15%) and partial thromboplastin time (PTT) within
             normal limits (plus or minus 15%).

          -  Patient has a Karnofsky performance status (KPS) greater or equal to 70 (Eastern
             Cooperative Oncology Group [ECOG] PS 0-1).

          -  Patient has one or more metastatic tumors measurable by computed tomography (CT) scan.

          -  Patient has been informed about the nature of study, and has agreed to participate in
             the study, and signed the Informed Consent form prior to participation in any
             study-related activities.

        Exclusion Criteria:

          -  Patient has known brain metastases unless previously treated and well controlled for
             at least 3 months (defined as stable clinically, no edema, no steroids and stable in
             two scans at least 4 weeks apart).

          -  Patient uses therapeutic coumadin for a history of pulmonary emboli and deep vein
             thrombosis (DVT).

          -  Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
             systemic therapy.

          -  Patient has known infection with human immunodeficiency virus (HIV), hepatitis B,
             hepatitis C.

          -  Patient has undergone major surgery, other than diagnostic surgery i.e.-- done to
             obtain a biopsy for diagnosis without removal of an organ), with 4 weeks prior to Day
             1 of treatment in this study.

          -  Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy
             within 3 weeks prior to study entry weeks (6 weeks for nitrosureas or mitomycin C).

          -  Patient has a history of allergy or hypersensitivity to the study drug.

          -  Patient has serious medical risk factors involving any of the major organ systems such
             that the investigator considers it unsafe for the patient to receive an experimental
             research drug.

          -  Patient is unwilling or unable to comply with study procedures.

          -  Patient is enrolled in any other clinical protocol or investigational trial.