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Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Pancreatic Carcinoma Non-resectable, Stage IV Pancreatic Cancer

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Trial Information

Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer

This study will help determine whether the occurrence of adverse events can be decreased by
moving to a bi-weekly, opposed to a weekly dosing schedule of gemcitabine plus nab-Pacitaxel
for the treatment of unresectable/metastatic pancreatic cancer.

Inclusion Criteria:

1. Patients must have histologically-proven unresectable/metastatic pancreatic

2. Patient has one or more radiographically measurable tumor.

3. Patients may have received prior therapy with gemcitabine alone or with
fluoropyrimidines, erlotinib or radiation therapy (RT) in the past.

4. Age ≥ 18 years.

5. Patient or legal representative must have read, understood and provided written
informed consent and HIPAA authorization after full explanation of the nature of the

6. ECOG performance status 0 - 2 and an expected survival of at least 3 months.

7. Acceptable hematological parameters within 2 weeks of commencing study therapy as

- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

- Platelet count ≥ 100 x 109/L

- Hemoglobin (Hgb) ≥ 9g/dl

8. Patients with adequate organ function as measured by:

A. Cardiac: American Heart Association Class I: Patients with cardiac disease but
without resulting limitation of physical activity. Ordinary physical activity does
not cause undue fatigue, palpitation, dyspnea, or anginal pain. Hepatic: Bilirubin <
2.0 mg/ and ALT and AST < 1.5x the upper limit of normal.

B. Renal: Creatinine < 1.5 mg/dl and no other chronic kidney disease.

9. Women must meet one of the following criteria:

- Post-menopausal for at least one year

- Surgically incapable of child-bearing

- Utilizing a reliable form of contraception for the duration of study

Women of child-bearing potential must have a negative serum β-HCG within 7 days of study
drug administration.


Exclusion Criteria:

1. Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as
monotherapy or combination in neo-adjuvant, adjuvant or the metastatic setting.

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

3. Other significant active or chronic infection.

4. History of active other malignancy excluding basal or squamous cell carcinoma of the
skin or cervical intraepithelial neoplasia.

5. Pregnant or nursing females.

6. Patient has serious medical risk factors involving any of the major organ systems, or
serious psychiatric disorders, which could compromise the patient's safety or the
study data integrity.

7. Major surgery, other than diagnostic surgery within 4 weeks of study entry. -

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival based on toxicity profile of adverse events.

Outcome Description:

Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Madappa Kundranda, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Western Regional Medical Center


United States: Institutional Review Board

Study ID:

WRMC 12-25



Start Date:

February 2013

Completion Date:

February 2015

Related Keywords:

  • Pancreatic Carcinoma Non-resectable
  • Stage IV Pancreatic Cancer
  • Carcinoma
  • Pancreatic Neoplasms



Western Regional Medical CenterGoodyear, Arizona  85338