Trial record 1 of 1 for:    nabplagem
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Nab-Paclitaxel+Cisplatin+Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Pancreatic Cancer Research Team
Sponsor:
Collaborators:
Translational Genomics Research Institute, Phoenix, Arizona.
Translational Drug Development (TD2)
Virgina G. Piper Cancer Center - Clinical Trials
Information provided by (Responsible Party):
Gayle Jameson, Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier:
NCT01893801
First received: July 2, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Stage IV Pancreatic Cancer
Drug: nab-paclitaxel
Drug: Cisplatin
Drug: gemcitabine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Pancreatic Cancer Research Team:

Primary Outcome Measures:
  • Complete Response Rate [ Time Frame: 1 yr. ] [ Designated as safety issue: No ]

    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:
  • Evaluate disease control rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Evaluate disease control rate (CR, PR and SD at 9 weeks) in patients with metastatic PDA.

  • Evaluate treatment-related toxicities [ Time Frame: Over the course of the study ] [ Designated as safety issue: Yes ]
    Evaluate the treatment-related toxicities in this patient population.

  • Evaluate the change in CA 19-9 or other biomarkers [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]
    Evaluate the change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) in this patient population.


Estimated Enrollment: 25
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893801

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

Locations
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, Phoenix, Arizona.
Translational Drug Development (TD2)
Virgina G. Piper Cancer Center - Clinical Trials
Investigators
Principal Investigator: Gayle S Jameson, MSN ACNP-BC Scottsdale Health Care
  More Information

Additional Information:
No publications provided

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
Study First Received: July 2, 2013
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pancreatic Cancer Research Team:
pancreatic cancer
pancreatic adenocarcinoma
Stage IV pancreatic cancer
pancreas
pancreatic

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma, Ductal, Breast
Carcinoma
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
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Cisplatin
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014