NCT01893801

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2013

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 29, 2019

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

2.9 years

First QC Date

July 2, 2013

Results QC Date

March 28, 2019

Last Update Submit

May 5, 2019

Conditions

Stage IV Pancreatic Cancer

Keywords

pancreatic cancerpancreatic adenocarcinomaStage IV pancreatic cancerpancreaspancreatic

Outcome Measures

Primary Outcomes (1)

  • Complete Response Rate

    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.

    1 yr.

Secondary Outcomes (4)

  • Treatment-Related Toxicities

    Over the course of the subjects' treatment on study, approx 1 year

  • Percentage Change in CA 19-9

    Over the course of the subjects' treatment on study, approx 1 year

  • Overall Survival

    Over the course of the subjects' treatment and participation in study, approx 18 mos

  • Progression-Free Survival

    Over the course of the subjects' treatment and participation in study, approx 18 mos

Study Arms (1)

nab-paclitaxel+Cisplatin+gemcitabine

EXPERIMENTAL

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-paclitaxelDrug: CisplatinDrug: gemcitabine

Interventions

nab-paclitaxelDRUG

25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Also known as: Abraxane
nab-paclitaxel+Cisplatin+gemcitabine
CisplatinDRUG

25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle

Also known as: cisplatinum, cis-diamminedichloroplatinum, CDDP
nab-paclitaxel+Cisplatin+gemcitabine
gemcitabineDRUG

1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Also known as: Gemzar
nab-paclitaxel+Cisplatin+gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Scottsdale Health Care

Scottsdale, Arizona, 85260, United States

Location

Rutgers - Cancer Institute of New Jersey (CINJ)

New Brunswick, New Jersey, 08901, United States

Location

Vita Medical Associates, PC

Bethlehem, Pennsylvania, 18015, United States

Location

Related Publications (3)

  • Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3.

    PMID: 21969517BACKGROUND

  • 2013 Gastrointestinal Cancers Symposium. Abstract LBA148. Presented January 25, 2013

    BACKGROUND

  • Jameson GS, Borazanci E, Babiker HM, Poplin E, Niewiarowska AA, Gordon MS, Barrett MT, Rosenthal A, Stoll-D'Astice A, Crowley J, Shemanski L, Korn RL, Ansaldo K, Lebron L, Ramanathan RK, Von Hoff DD. Response Rate Following Albumin-Bound Paclitaxel Plus Gemcitabine Plus Cisplatin Treatment Among Patients With Advanced Pancreatic Cancer: A Phase 1b/2 Pilot Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):125-132. doi: 10.1001/jamaoncol.2019.3394.

    PMID: 31580386DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxelAlbumin-Bound PaclitaxelCisplatinGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Adam Rosenthal
Organization
Cancer Research and Biostatistics
adamr@crab.org
(206) 839-1797

Study Officials

  • Gayle S Jameson, MSN ACNP-BC

    Scottsdale Health Care

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Principal Investigator

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 9, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2016

Study Completion

October 1, 2017

Last Updated

May 29, 2019

Results First Posted

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)