Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Abraxane
Intervention description: One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
      formulation, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle
      formulation works in treating patients with locally advanced or metastatic pancreatic cancer
      that did not respond to first-line therapy with gemcitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically confirmed, locally advanced (unresectable) or
             metastatic pancreatic cancer, and have failed first-line treatment with a
             gemcitabine-containing regimen.

          2. Patients have to be 18 years-old or older

          3. Able to give signed Informed consent

          4. Adequate end-organ function with laboratory parameters as follows:

               -  Neutrophils: 1.5 x10^9/L or greater

               -  Plts: 100 x10^9/L or greater

               -  Hemoglobin: ≥ 9.0g/dL

               -  Serum Creatinine: ≤ 1.5mg/dL

               -  Bilirubin: ≤ 1.5 times the upper limit of the normal range (ULN)

               -  Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times ULN

          5. Adequate contraception: For female (or male) patients, either post-menopausal, or for
             pre-menopausal surgically sterilized, or willing to use an acceptable method of birth
             control for the duration of the study

          6. Measurable or non-measurable disease by RECIST criteria

          7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

          8. Patients must be at least 3 weeks from prior therapies and must have recovered from
             prior toxicity

          9. Life expectancy greater than 3 months

         10. Willing and able to comply with the protocol requirement.

         11. Patients must not have any peripheral neuropathy equal or greater than grade 2

        Exclusion Criteria:

          1. Chemotherapy within 3 weeks prior to enrollment

          2. Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks
             prior to enrollment.

          3. Any major surgery within 4 weeks prior to enrollment

          4. Peripheral neuropathy equal to or greater than grade 2

          5. Clinical AIDS or known positive HIV serology

          6. Evidence of concurrent, clinically evident malignancy, except inactive non-melanoma
             skin cancer and inactive cervical cancer diagnosed or other cancer for which the
             patient has been disease-free for five years

          7. Unstable angina

          8. New York Heart Association (NYHA) Grade II or greater congestive heart failure

          9. History of myocardial infarction within 3 months

         10. History of stroke within 3 months

         11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to enrollment, anticipation of need for major surgical procedure during the
             course of the study

         12. Pregnant (positive pregnancy test) or lactating

         13. Inability to comply with study and/or follow-up procedures

         14. Participants with serious medical or psychiatric illness that would render
             chemotherapy unsafe are ineligible.

         15. Participants cannot have been in another experimental drug study within 4 weeks of the
             first infusion of these study medications.