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

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ClinicalTrials.gov Identifier: NCT01851174
Recruitment Status : Terminated (PI Leaving Site)
First Posted : May 10, 2013
Results First Posted : December 4, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Carcinoma Non-resectable Stage IV Pancreatic Cancer Drug: Gemcitabine Drug: nab-Paclitaxel Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the First Line Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer
Study Start Date : February 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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Arms and Interventions
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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 Name: Gemzar

Drug: nab-Paclitaxel
Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion
Other Name: Abraxane


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


Secondary Outcome Measures :
  1. Progression Free Survival Time [ Time Frame: One year ]
    Determine progression free survival time with this regimen


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851174


Locations
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United States, Arizona
Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Investigators
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Principal Investigator: Madappa Kundranda, MD, PhD Western Regional Medical Center
More Information
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Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01851174    
Other Study ID Numbers: WRMC 12-25
First Posted: May 10, 2013    Key Record Dates
Results First Posted: December 4, 2017
Last Update Posted: February 7, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs