Study of Gemcitabine and Abraxane for Pancreas Cancer

NCT02242409 | Terminated Phase 2 DMC

• 1 other identifier: LCCC 2013-0138
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 4 month progression free survival

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

  2.5 years

Secondary Outcomes (3)

• Disease control rate

  2.5 years

• Progression Free Survival

  2.5 years

• Overall Survival

  3 years

Study Arms (1)

Gemcitabine/abraxane

EXPERIMENTAL

Gemcitabine and Abraxane

Drug: Gemcitabine and Abraxane

Interventions

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

Also known as: Gemzar, nanoparticle-bound paclitaxel, Nab-paclitaxel

Gemcitabine/abraxane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Pishvaian, MD PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

US (1)