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Study of Gemcitabine and Abraxane for Pancreas Cancer

Primary Purpose

Pancreatic Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine and Abraxane

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Metastatic pancreatic cancer, Second Line treatment, Gemcitabine, Nab-paclitaxel

Eligibility Criteria

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

Inclusion Criteria:

Histologically confirmed metastatic adenocarcinoma of the pancreas
Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease
Radiographically measurable or evaluable disease
Age >/= 18 years
ECOG performance status 0-2
Adequate hepatic, bone marrow and renal function

Exclusion Criteria:

Prior gemcitabine-based chemotherapy in the first line setting
No active severe infection, or known chronic infection with HIV or hepatitis B virus
No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception
Patients with known CNS metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel
Anticipated patient survival under 2 months

Sites / Locations

Georgetown Lombardi Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine/abraxane

Arm Description

Gemcitabine and Abraxane

Outcomes

Primary Outcome Measures

4 month progression free survival

The proportion of patients at 4 months from study entry with progression or death

Secondary Outcome Measures

Disease control rate

Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria

Progression Free Survival

The time in days from study entry until progression or death

Overall Survival

The time in days from study entry until death

Full Information

NCT ID

NCT02242409

First Posted

September 12, 2014

Last Updated

February 13, 2017

Sponsor

Georgetown University

1. Study Identification

Unique Protocol Identification Number

NCT02242409

Brief Title

Study of Gemcitabine and Abraxane for Pancreas Cancer

Official Title

A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

Testing of combination no longer relevant

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Georgetown University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting

Detailed Description

This is an open label Phase II study to evaluate the clinical activity of the combination of gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The hypothesis is that this combination will have a 4-month progression free survival of 70% or higher.

6. Conditions and Keywords

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

Pancreatic Cancer

Keywords

Metastatic pancreatic cancer, Second Line treatment, Gemcitabine, Nab-paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine/abraxane

Arm Type

Experimental

Arm Description

Gemcitabine and Abraxane

Intervention Type

Drug

Intervention Name(s)

Gemcitabine and Abraxane

Other Intervention Name(s)

Gemzar, nanoparticle-bound paclitaxel, Nab-paclitaxel

Intervention Description

Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days

Primary Outcome Measure Information:

Title

4 month progression free survival

Description

The proportion of patients at 4 months from study entry with progression or death

Time Frame

2.5 years

Secondary Outcome Measure Information:

Title

Disease control rate

Description

Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria

Time Frame

2.5 years

Title

Progression Free Survival

Description

The time in days from study entry until progression or death

Time Frame

2.5 years

Title

Overall Survival

Description

The time in days from study entry until death

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed metastatic adenocarcinoma of the pancreas Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease Radiographically measurable or evaluable disease Age >/= 18 years ECOG performance status 0-2 Adequate hepatic, bone marrow and renal function Exclusion Criteria: Prior gemcitabine-based chemotherapy in the first line setting No active severe infection, or known chronic infection with HIV or hepatitis B virus No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception Patients with known CNS metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel Anticipated patient survival under 2 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Pishvaian, MD PhD

Organizational Affiliation

Georgetown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgetown Lombardi Comprehensive Cancer Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of Gemcitabine and Abraxane for Pancreas Cancer

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