Study of Gemcitabine and Abraxane for Pancreas Cancer | NCT02242409

Studies
Study of Gemcitabine and Abraxane for Pancreas Cancer

NCT02242409

Sponsor

Georgetown University

Status

Terminated

Last Update Posted

Feb 14, 2017Actual

Enrollment

4Actual

Phase

Phase 2

Conditions

Pancreatic Cancer

Interventions

Gemcitabine and Abraxane

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Testing of combination no longer relevant

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Sep 12, 2014

First Submission Date that Met QC Criteria

Sep 16, 2014

First Posted Date

Sep 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2017

Last Update Posted Date

Feb 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gemcitabine/abraxane	Experimental	Gemcitabine and Abraxane	Drug: Gemcitabine and Abraxane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine and Abraxane	Drug	Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days	Gemcitabine/abraxane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
4 month progression free survival	The proportion of patients at 4 months from study entry with progression or death	2.5 years

Secondary Outcomes

Measure	Description	Time Frame
Disease control rate	Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria	2.5 years
Progression Free Survival	The time in days from study entry until progression or death

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Pishvaian, MD PhD	Georgetown University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown Lombardi Comprehensive Cancer Center		Washington D.C.	District of Columbia	20007	United States

Type	Date	Date Unknown
Release	Oct 7, 2019
Reset	Oct 29, 2019
Release	Mar 16, 2020
Reset	Mar 24, 2020

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
D000068196	Albumin-Bound Paclitaxel
C520255	130-nm albumin-bound paclitaxel

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 7, 2019			Oct 29, 2019
Mar 16, 2020