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

This study is currently recruiting participants.
Verified May 2013 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Madappa Kundranda, MD, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01851174
First received: February 15, 2013
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Pancreatic Carcinoma Non-resectable
Stage IV Pancreatic Cancer
Drug: Gemcitabine
Drug: nab-Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • Overall survival based on toxicity profile of adverse events. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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:
  • Progression free survival time [ Time Frame: One year ] [ Designated as safety issue: No ]
    Determine progression free survival time with this regimen

  • Response rate [ Time Frame: One year ] [ Designated as safety issue: No ]
    Determine response rate with this regimen

  • Duration of response with this regimen [ Time Frame: One year ] [ Designated as safety issue: No ]
    Determine duration of response with this regimen


Estimated Enrollment: 26
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine and nab-Paclitaxel

Gemcitabine (1,000/m2)administered intravenously on days 1 and 15, every 28 days

nab-Paclitaxel (125mg/m2)administered intravenously on days 1 and 15, every 28 days

Drug: Gemcitabine
Patients will receive Gemcitabine (1,000mg/m2) IV over 30 minutes after nab-paclitaxel infusion
Other Name: Gemzar
Drug: nab-Paclitaxel
Patients will receive nab-Paclitaxel (125mg/m2) IV over 30 minutes before Gemcitabine infusion
Other Name: Abraxane

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 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 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 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. 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. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851174

Contacts
Contact: Karen V Kohl, RN, CCRC 623-207-3000 karen.kohl@ctca-hope.com
Contact: India Hill, CCRP 623-207-3000 india.hill@ctca-hope.com

Locations
United States, Arizona
Western Regional Medical Center Recruiting
Goodyear, Arizona, United States, 85338
Principal Investigator: Madappa N. N Kundranda, MD, PHD         
Sponsors and Collaborators
Western Regional Medical Center
Investigators
Principal Investigator: Madappa Kundranda, MD, PhD Western Regional Medical Center
  More Information

No publications provided

Responsible Party: Madappa Kundranda, MD, MD, PhD, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01851174     History of Changes
Other Study ID Numbers: WRMC 12-25
Study First Received: February 15, 2013
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014