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Nab-Paclitaxel+Cisplatin+Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)

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ClinicalTrials.gov Identifier: NCT01893801
Recruitment Status : Unknown
Verified February 2014 by Gayle Jameson, Pancreatic Cancer Research Team.
Recruitment status was:  Recruiting
First Posted : July 9, 2013
Last Update Posted : March 3, 2014
Information provided by (Responsible Party):

Study Description
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 Multiple cycles may be administered until the patient is withdrawn from therapy.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).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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. Evaluate disease control rate [ Time Frame: 9 weeks ]
    Evaluate disease control rate (CR, PR and SD at 9 weeks) in patients with metastatic PDA.

  2. Evaluate treatment-related toxicities [ Time Frame: Over the course of the study ]
    Evaluate the treatment-related toxicities in this patient population.

  3. Evaluate the change in CA 19-9 or other biomarkers [ Time Frame: Over the course of the study ]
    Evaluate the change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) in this patient population.

Eligibility Criteria

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

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.
Contacts and Locations

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

Contact: Amy Stoll-D'Astice, MS, CCRP (602) 358-8319 astoll@td2inc.com

United States, Arizona
Scottsdale Health Care Recruiting
Scottsdale, Arizona, United States, 85260
Contact: Joyce Schaffer, MSN RN AOCNS    480-323-1339    joschaffer@shc.org   
Principal Investigator: Gayle S Jameson, MSN ACNP-BC         
Sub-Investigator: Ramesh K Ramanathan, MD         
Sub-Investigator: Daniel D Von Hoff, MD FACP         
Sub-Investigator: Katy B Schroeder, RN BSN OCN         
United States, New Jersey
Rutgers - Cancer Institute of New Jersey (CINJ) Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Anjali Krishnan, RN    732-235-8996    warrieac@cinj.rutgers.edu   
Contact: Tatianna Zelinskaya    732-235-9837    zelinska@cinj.rutgers.edu   
Principal Investigator: Elizabeth Popllin, MD         
United States, Pennsylvania
Vita Medical Associates, PC Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Colleen Saitta, NP    610-866-0113    nurses@vitahemonc.org   
Contact: Gulyun Zhou, NP    610-866-0113    nurses@vitahemonc.org   
Principal Investigator: Anna A Niewiarowska, MD         
Sponsors and Collaborators
Gayle Jameson
Translational Genomics Research Institute
Translational Drug Development
Virgina G. Piper Cancer Center - Clinical Trials
Principal Investigator: Gayle S Jameson, MSN ACNP-BC Scottsdale Health Care
More Information

Additional Information:
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
Last Update Posted: March 3, 2014
Last Verified: February 2014

Keywords provided by Gayle Jameson, Pancreatic Cancer Research Team:
pancreatic cancer
pancreatic adenocarcinoma
Stage IV pancreatic cancer

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