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A Pilot Phase II Multi Center Study of Gemcitabine and Nab-paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Resectable Pancreatic Cancer

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Trial Information

A Pilot Phase II Multi Center Study of Gemcitabine and Nab-paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer

The best outcome for a patient diagnosed with pancreatic cancer is surgery. However many
patients have recurrence of the cancer after successful surgery. The investigators are
evaluating chemotherapy before surgery, which is a new approach.

In this study, Abraxane and gemcitabine will be tested as treatment for people with operable
pancreatic cancer to see if surgery can be successfully performed and if treatment will
reduce cancer cells in the tumor at surgery.

Abraxane is approved by the US FDA for the treatment of metastatic breast cancer after
failure of combination chemotherapy for metastatic disease or relapse within 6 months of
adjuvant chemotherapy. Gemcitabine is approved by the FDA for first line treatment for
patients with locally advanced or metastatic cancer of the pancreas.

Inclusion Criteria:

1. Patient has histologically or cytologically confirmed potentially resectable
adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.

Definition of potentially operable disease

1. Staging by high-quality, pancreatic protocol, helical abdominal computed
tomography required (Endoscopic ultrasound is not required).

2. No extension to superior mesenteric artery (SMA) and hepatic artery.

3. Clear fat plane between the SMA and celiac axis.

4. No extension to celiac axis and hepatic artery.

5. Patent superior mesenteric vein and portal vein.

6. No evidence of distant or extra-hepatic disease by CT scans.

7. Pretreatment histological or cytological confirmation of an adenocarcinoma.

2. Male or non-pregnant and non-lactating female, and ≥ 18 years of age.

3. If a female patient is of child-bearing potential, she must have a negative serum
pregnancy test (β hCG) documented within 72 hours of the first administration of
study drug.

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

5. Patient must have received no prior chemotherapy or radiation for pancreatic cancer
and no exposure to gemcitabine and/or Abraxane

6. Patient has the following blood counts at baseline:

1. ANC ≥ 1.5 x 109/L (1500 /mm³);

2. Platelets ≥ 100 x 109/L; (100,000/mm³);

3. Hgb ≥ 10 g/dL.

7. Patient has the following blood chemistry levels at baseline:

1. AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN);

2. Alkaline phosphatase (AP) ≤ 2.5 X ULN;

3. Total bilirubin ≤1.5 mg/dl;

4. Serum creatinine ≤1.5mg/dl or calculated clearance ≥ 50 mL/min/1.73 m² for
patients with serum creatinine levels >1.5 mg/dl.

8. Patient has acceptable coagulation status as indicated by a PT within normal limits
(±15%) and PTT within normal limits (± 15%).

9. Patient has an ECOG performance status PS 0-1.

10. Patient has been informed about the nature of the 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:

1. Patient has borderline resectable disease

2. Patient uses therapeutic coumadin for a history of pulmonary emboli or DVT.

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

4. Patient has known infection with HIV, hepatitis B, or hepatitis C.

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

6. Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine
and/or Abraxane.

7. Patient has a history of allergy or hypersensitivity to the study drugs.

8. 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.

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

10. Patient is enrolled in any other therapeutic clinical protocol or investigational

11. Patient has metastatic disease on radiological staging.

12. Patients aged ≥ 80 are not excluded. As two events of fatal sepsis have been seen in
this group in other studies, candidates in this age group should be thoroughly
evaluated before enrollment in the study, to ensure they are fit to receive
chemotherapy. In addition to meeting all of the baseline patient selection criteria,
clinical judgment on their susceptibility to infection and expected stability of
their performance status as to receive repeat weekly chemotherapy cycles, should be
paid special attention to. Patients should not be enrolled in the study should there
be any hesitation on any of these considerations. Baseline criteria for all patients
enrolled on the study must be carefully evaluated and all criteria followed

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade III/IV histological response in tumor specimen rate after induction therapy.

Outcome Time Frame:

At time of surgery

Safety Issue:


Principal Investigator

Ramesh K. Ramanathan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

TGen Drug Development


United States: Food and Drug Administration

Study ID:

PCRT 10-001



Start Date:

May 2011

Completion Date:

March 2016

Related Keywords:

  • Resectable Pancreatic Cancer
  • operable
  • pancreas
  • Abraxane
  • Gemcitabine
  • Preoperative
  • potentially
  • Pancreatic Cancer
  • Pancreatic Neoplasms



Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258
University of Pittsburg Medical CenterPittsburg, Pennsylvania  15213
St Mary's / Trinity Health CareGrand Rapids, Michigan  49505