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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

Tracking Information
First Submitted Date  ICMJE July 2, 2013
First Posted Date  ICMJE July 9, 2013
Results First Submitted Date  ICMJE March 28, 2019
Results First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 29, 2019
Study Start Date  ICMJE May 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
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 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 CR is documented, a confirmatory PET scan will be obtained. If 1 or more of 10 patients demonstrate a complete response, 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • Treatment-Related Toxicities [ Time Frame: Over the course of the subjects' treatment on study, approx 1 year ]
    Frequency of treatment-related toxicities
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Evaluate disease control rate [ Time Frame: 9 weeks ]
Evaluate disease control rate (CR, PR and DS at 9 weeks) in patients with metastatic PDA. Evaluate the treatment-related toxicities in this patient population. Evaluate the change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) in this patient population.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA
Official Title  ICMJE A Phase 1b/2 Pilot Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)
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).
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stage IV Pancreatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: nab-paclitaxel
  • Drug: Cisplatin
  • Drug: gemcitabine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2013)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2017
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893801
Other Study ID Numbers  ICMJE PCRT 12-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gayle Jameson, Pancreatic Cancer Research Team
Study Sponsor  ICMJE Pancreatic Cancer Research Team
Collaborators  ICMJE
  • Translational Genomics Research Institute
  • Honor Health - Clinical Trials
  • Cancer Research and Biostatistics Clinical Trials Consortium
Investigators  ICMJE
Principal Investigator: Gayle S Jameson, MSN ACNP-BC Scottsdale Health Care
PRS Account Pancreatic Cancer Research Team
Verification Date May 2019

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