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

Primary Purpose

Stage IV Pancreatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

nab-paclitaxel

Cisplatin

gemcitabine

About this trial

This is an interventional treatment trial for Stage IV Pancreatic Cancer focused on measuring pancreatic cancer, pancreatic adenocarcinoma, Stage IV pancreatic cancer, pancreas, pancreatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Scottsdale Health Care
Rutgers - Cancer Institute of New Jersey (CINJ)
Vita Medical Associates, PC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nab-paclitaxel+Cisplatin+gemcitabine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Treatment-Related Toxicities

Frequency of treatment-related toxicities

Percentage Change in CA 19-9

Percentage change in CA 19-9 from baseline values

Overall Survival

Overall survival is defined as the time from study enrollment until death from any cause.

Progression-Free Survival

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.

Full Information

NCT ID

NCT01893801

First Posted

July 2, 2013

Last Updated

May 5, 2019

Sponsor

Pancreatic Cancer Research Team

Collaborators

Translational Genomics Research Institute, Honor Health - Clinical Trials, Cancer Research and Biostatistics Clinical Trials Consortium

1. Study Identification

Unique Protocol Identification Number

NCT01893801

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pancreatic Cancer Research Team

Collaborators

Translational Genomics Research Institute, Honor Health - Clinical Trials, Cancer Research and Biostatistics Clinical Trials Consortium

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IV Pancreatic Cancer

Keywords

pancreatic cancer, pancreatic adenocarcinoma, Stage IV pancreatic cancer, pancreas, pancreatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nab-paclitaxel+Cisplatin+gemcitabine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

nab-paclitaxel

Other Intervention Name(s)

Abraxane

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

cisplatinum, cis-diamminedichloroplatinum, CDDP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete Response Rate

Description

Time Frame

1 yr.

Secondary Outcome Measure Information:

Title

Treatment-Related Toxicities

Description

Frequency of treatment-related toxicities

Time Frame

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

Title

Percentage Change in CA 19-9

Description

Percentage change in CA 19-9 from baseline values

Time Frame

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

Title

Overall Survival

Description

Overall survival is defined as the time from study enrollment until death from any cause.

Time Frame

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

Title

Progression-Free Survival

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gayle S Jameson, MSN ACNP-BC

Organizational Affiliation

Scottsdale Health Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

Scottsdale Health Care

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85260

Country

United States

Facility Name

Rutgers - Cancer Institute of New Jersey (CINJ)

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Vita Medical Associates, PC

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21969517

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

31580386

Citation

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. 2019 Oct 3;6(1):125-32. doi: 10.1001/jamaoncol.2019.3394. Online ahead of print. Erratum In: JAMA Oncol. 2019 Nov 1;5(11):1643.

Results Reference

derived

Links:

URL

http://www.tgen.org

Description

Non-profit Organization

URL

http://www.td2inc.com

Description

Learn more about this trial

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

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