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Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA

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ClinicalTrials.gov Identifier: NCT01893801
Recruitment Status : Completed
First Posted : July 9, 2013
Results First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborators:
Translational Genomics Research Institute
Honor Health - Clinical Trials
Cancer Research and Biostatistics Clinical Trials Consortium
Information provided by (Responsible Party):
Gayle Jameson, Pancreatic Cancer Research Team

Brief Summary:
The primary objective of this study is to determine the efficacy of nab-paclitaxel plus cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma (PDA).

Condition or disease Intervention/treatment Phase
Stage IV Pancreatic Cancer Drug: nab-paclitaxel Drug: Cisplatin Drug: gemcitabine Phase 1 Phase 2

Detailed Description:

This is a phase 1b/2 open-label pilot study evaluating the preliminary efficacy and safety of nab-paclitaxel, cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.

An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles may be administered until the patient is withdrawn from therapy.

Overall response rates as well as individual categories of response (complete response-CR, partial response-PR, stable disease-SD and progressive disease-PD) will be determined using RECIST 1.1. Time-to-event endpoints, including progression free survival (PFS) and OS (overall survival) will be assessed using the Kaplan-Meier method. Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE (v4.0, May 2009).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Pilot Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)
Study Start Date : May 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : October 1, 2017


Arm Intervention/treatment
Experimental: nab-paclitaxel+Cisplatin+gemcitabine
This is a phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of nab-paclitaxel 125mb/m2, cisplatin 25mg/m2, and gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression.
Drug: nab-paclitaxel
25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Other Name: Abraxane

Drug: Cisplatin
25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle
Other Names:
  • cisplatinum
  • cis-diamminedichloroplatinum
  • CDDP

Drug: gemcitabine
1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Other Name: Gemzar




Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: 1 yr. ]

    The primary objectives of this study is to pursue treatment of 25 individual patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDA) to evaluate:

    Complete response rate as defined by computed tomography (CT) scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2x ULN). We expect to accomplish this in > or = to 5% of patients. When a complete response (CR) is documented, a confirmatory PET scan will be obtained.

    If 1 or more of 10 patients demonstrate a complete response (CR), study will continue to enroll to a total of 25 patients.

    If intolerable adverse events or no clinical benefit are noted in the first 6 patients, study will discontinue enrollment.



Secondary Outcome Measures :
  1. Treatment-Related Toxicities [ Time Frame: Over the course of the subjects' treatment on study, approx 1 year ]
    Frequency of treatment-related toxicities

  2. Percentage Change in CA 19-9 [ Time Frame: Over the course of the subjects' treatment on study, approx 1 year ]
    Percentage change in CA 19-9 from baseline values

  3. Overall Survival [ Time Frame: Over the course of the subjects' treatment and participation in study, approx 18 mos ]
    Overall survival is defined as the time from study enrollment until death from any cause.

  4. Progression-Free Survival [ Time Frame: Over the course of the subjects' treatment and participation in study, approx 18 mos ]
    Progression-free survival is defined as the time from study enrollment until the first documented tumor progression (using RECIST 1.1 criteria) or death from any cause.



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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:

  • Age >18 years of age; male or female.
  • Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
  • Capable of providing informed consent and complying with trial procedures.
  • Karnofsky Performance Status (KPS) of >/=70%.
  • Life expectancy >/=12 weeks.
  • Measurable tumor lesions according to RECIST 1.1 criteria.
  • Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.

Exclusion Criteria:

  • Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
  • Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
  • Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
  • Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
  • History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for >/= 5 years.
  • Laboratory values: Screening serum creatinine > upper limits of normal (ULN); total bilirubin > ULN: alanine aminotransferase (ALT) and AST >/= 2.5 ULN or >/= 5.0 x ULN if liver metastases are present; absolute neutrophil count < 1,500/mm3, platelet concentration < 100,00/mm3, hematocrit level < 27% for females or < 30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) > 1.5 x ULN unless on therapeutic doses of warfarin.
  • current, serious, clinically significant cardiac arrhythmias as determined by the Investigator.
  • History of HIV infection.
  • Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
  • Major surgery within 4 weeks prior to initiation of study treatment. Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.
  • Any condition that is unstable and could jeopardize the patient's participation in the study.

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): NCT01893801


Locations
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United States, Arizona
Scottsdale Health Care
Scottsdale, Arizona, United States, 85260
United States, New Jersey
Rutgers - Cancer Institute of New Jersey (CINJ)
New Brunswick, New Jersey, United States, 08901
United States, Pennsylvania
Vita Medical Associates, PC
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
Pancreatic Cancer Research Team
Translational Genomics Research Institute
Honor Health - Clinical Trials
Cancer Research and Biostatistics Clinical Trials Consortium
Investigators
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Principal Investigator: Gayle S Jameson, MSN ACNP-BC Scottsdale Health Care

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gayle Jameson, Lead Principal Investigator, Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier: NCT01893801     History of Changes
Other Study ID Numbers: PCRT 12-001
First Posted: July 9, 2013    Key Record Dates
Results First Posted: May 29, 2019
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gayle Jameson, Pancreatic Cancer Research Team:
pancreatic cancer
pancreatic adenocarcinoma
Stage IV pancreatic cancer
pancreas
pancreatic
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
Albumin-Bound Paclitaxel
Cisplatin
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