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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

February 15, 2013
May 9, 2013
February 2013
February 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01851174 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer
Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the 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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Carcinoma Non-resectable
  • Stage IV Pancreatic Cancer
  • 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
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

Interventions:
  • Drug: Gemcitabine
  • Drug: nab-Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26
February 2015
February 2014   (final data collection date for primary outcome measure)

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. -
Both
18 Years and older
No
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
United States
 
NCT01851174
WRMC 12-25
No
Madappa Kundranda, MD, Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Madappa Kundranda, MD, PhD Western Regional Medical Center
Western Regional Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP