Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

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

To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

Study Overview

• Status: Terminated
• Conditions: Stage IV Pancreatic Cancer; Pancreatic Carcinoma Non-resectable
• Intervention / Treatment: Drug: Gemcitabine; Drug: nab-Paclitaxel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Western Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.
2. Patient has one or more radiographically measurable tumor.
3. Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).
4. Age ≥ 18 years.
5. Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.
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 follows:

   • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
   • Platelet count ≥ 100 x 10^9/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.

   B. Hepatic: Bilirubin ≤ 2.0 mg/ and ALT and AST ≤ 1.5x the upper limit of normal.

   C. 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 participation. 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. Previous use of any chemotherapy or radiation therapy for metastatic disease.
3. 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).
4. Other significant active or chronic infection.
5. History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
6. Pregnant or nursing females.
7. 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.
8. Major surgery, other than diagnostic surgery within 4 weeks of study entry.
9. Patient requires a legal authorized representative for consenting.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gemcitabine and nab-Paclitaxel; Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days	Drug: Gemcitabine; Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion; Other Names: Gemzar; Drug: nab-Paclitaxel; Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion; Other Names: Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Based on Toxicity Profile of Adverse Events.	Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival Time	Determine progression free survival time with this regimen	One year

Collaborators and Investigators

• Sponsor: Western Regional Medical Center
• Investigators: Principal Investigator: Madappa Kundranda, MD, PhD, Western Regional Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: February 15, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (ESTIMATE): May 10, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Paclitaxel
• Other Study ID Numbers: WRMC 12-25