Clinical trial NCT00417287 (phase 2, status: terminated)
Conditions: pancreatic neoplasms
ICD codes: C25.3
Drugs: px-12
SMILES: CCC(C)SSC1=NC=CN1
Reason stopped: 
    investigator decision
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically- or cytologically-confirmed diagnosis of advanced carcinoma of the
             pancreas (stage IV disease only).

          -  Patients whose tumor has progressed on gemcitabine or on a gemcitabine-containing
             combination. Patients must have received no more than two prior regimens for
             metastatic disease. Use of gemcitabine as a radiation sensitizer in combination with
             radiotherapy for localized disease will not be considered a prior
             gemcitabine-containing regimen if gemcitabine was received for ≤ 1 month following
             completion of radiotherapy. In addition, the use of 5-fluorouracil as a radiation
             sensitizer for localized disease will be allowed and not counted as a prior regimen if
             the 5-FU was continued for ≤ 1month following completion of radiotherapy.

          -  Karnofsky Performance Status of ≥ 70%.

          -  Patients must have discontinued previous anti-cancer therapy or other investigational
             agent at least three weeks or within 5 half lives of the drug (whichever is shorter)
             prior to entry into the study (six weeks for mitomycin C or nitrosureas) provided that
             all toxicities from prior treatment have resolved to a Grade 1 or less.

          -  Patients must have discontinued radiation therapy at least two weeks prior to entry
             into the study and have recovered from all radiation-related toxicities.

          -  Adequate organ function including the following:

          -  ANC ≥ 1500 cells/microL; platelets > 100,000/microL; hemoglobin ≥ 9 g/dL (may be
             transfused to this level).

          -  Bilirubin ≤ 2.0 mg/dL; aspartate transaminase (AST/SGOT) and alanine transaminase
             (ALT/SGPT) ≤ 3.0 times institutional upper limit of normal (ULN) OR < 5 times
             institutional ULN if the subject has documented liver metastases.

          -  Creatinine ≤2.0 mg/dL.

          -  CA19-9 level >2 times ULN.

          -  Disease that is measurable by CT scan per RECIST criteria (Appendix IV).

          -  PET/CT or PET scan with SUV of ≥ 5.0 in at least one lesion on an 18F FDG scan.

        Exclusion Criteria:

          -  Active infection requiring antibiotics at study entry.

          -  Any serious concomitant systemic disorder that in the opinion of the investigator
             would place the patient at excessive or unacceptable risk of toxicity.

          -  Patients with active (requiring continuous medical therapy) pulmonary disease (COPD,
             asthma) or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline
             chest X-ray or PET/CT scan.

          -  Significant central nervous system or psychiatric disorder(s) that preclude the
             ability of the patient to provide informed consent.

          -  Known or suspected brain metastases that have not received adequate therapy. Patients
             must be stable without requirement for steroids or seizure medications.

          -  Major surgery within 4 weeks of study entry.

          -  Chemotherapy/investigational drugs within 3 weeks or within 5 half lives of the drug
             (whichever is shorter) of study entry, provided that all toxicities from prior
             treatment have resolved to a Grade 1 or less.

          -  Inability to tolerate prophylactic (1 mg/day) coumadin.