Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer
Condition: Locally Advanced or Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: S-1
Intervention description: All participants received S-1 orally at a dose of 30 mg/m2 BID for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial was planned to proceed to the second stage only if sufficient efficacy was demonstrated in Stage 1.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether S-1 is effective in slowing tumor activity
      in participants with locally advanced or metastatic pancreatic cancer who have not had
      chemotherapy. The study is also looking at the safety of S-1.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has provided written informed consent.

          2. Has histologically or cytologically confirmed locally advanced, unresectable or
             metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or
             surgery.

          3. Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors
             (RECIST) criteria (ie, lesions that can be accurately measured in at least one
             dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm
             using spiral computed tomography [CT] scan).

          4. Is able to take medications orally.

          5. Is 18 years of age or older.

          6. Has a Karnofsky Performance Status (KPS) ≥ 70%.

          7. Has a life expectancy of ≥ 12 weeks.

          8. Has adequate organ function as defined by the following criteria:

               1. Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal
                  (ULN). If liver function abnormalities are due to underlying liver metastasis,
                  then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN.

               2. Total serum bilirubin ≤ 3.0 times ULN (if due to underlying liver metastasis,
                  then total bilirubin may be ≤ 5 times ULN).

               3. Absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units
                  [IU]).

               4. Platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L).

               5. Hemoglobin value ≥ 9.0 g/dL.

               6. Calculated creatinine clearance ≥ 60 mL/min (based on serum creatinine)
                  (Cockcroft-Gault85 formula)

          9. Is willing and able to comply with scheduled visits, treatment plan, laboratory tests,
             and other study procedures.

        Exclusion Criteria:

          1. Has had treatment with any of the following within the specified time frame prior to
             study drug administration:

               1. Any prior anticancer chemotherapy.

               2. Radiation therapy to a target lesion unless there was evidence of PD after
                  radiotherapy (and this target lesion must not be the only site of measurable
                  disease).

               3. Any radiotherapy within the previous 3 weeks.

               4. Any investigational agent received either concurrently or within the last 30
                  days.

               5. Current enrollment in another clinical study with an investigational agent.
                  Patients participating in surveys or observational studies are eligible to
                  participate in this study.

          2. Major surgery within the previous 3 weeks.

          3. Symptomatic brain metastasis not controlled by corticosteroids.

          4. Leptomeningeal metastasis.

          5. Previous or concurrent malignancy other than pancreatic cancer except adequately
             treated carcinoma in-situ of the cervix or non-melanoma skin cancer.

          6. Uncontrolled ascites requiring drainage at least twice a week.

          7. Other serious illness or medical condition(s) including, but not limited to, the
             following:

               1. Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class
                  III or IV), angina pectoris, arrhythmias, or hypertension.

               2. Active infection.

               3. Known (at time of entry) gastrointestinal disorder, including malabsorption,
                  chronic nausea, vomiting, or diarrhea, present to the extent that it might
                  interfere with oral intake and absorption of study medication.

               4. Poorly controlled diabetes mellitus.

               5. Psychiatric disorder that may interfere with consent and/or protocol compliance.

               6. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
                  (AIDS)-related illness.

               7. Other severe acute or chronic medical or psychiatric condition or laboratory
                  abnormality that may increase the risk associated with study participation or
                  study drug administration, or may interfere with the interpretation of study
                  results, and in the judgment of the Investigator would make the patient
                  inappropriate for entry into this study.

          8. Is receiving a concomitant treatment with drugs interacting with S-1. The following
             drugs are prohibited because there may be an interaction with S-1:

               1. Sorivudine, uracil, cimetidine, folinic acid, and dipyridamole (may enhance S-1
                  activity).

               2. Allopurinol (may diminish S-1 activity).

               3. Phenytoin (S-1 may enhance phenytoin activity).

               4. Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 and
                  flucytosine activity).

          9. Is a pregnant or lactating female.

         10. Has known sensitivity to 5-FU.

         11. Is a patient with reproductive potential who refuses to use an adequate means of
             contraception (including male patients).