A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer

This study has been completed.

Sponsor:

Collaborators:

Scottsdale Healthcare

Stand Up To Cancer

AACR

Information provided by:

TGen Drug Development Services

ClinicalTrials.gov Identifier:

NCT01196247

First received: September 3, 2010

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 3, 2010

Last Updated Date

July 16, 2012

Start Date ^ICMJE

September 2010

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine the percent of patients who are alive at one year [ Time Frame: One year ] [ Designated as safety issue: No ]

Goal is to improve the one year survival (from start of first-line therapy for metastatic disease) to 60%

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01196247 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer

Official Title ^ICMJE

Stand Up to Cancer Consortium: Phase II Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated With Metastatic Pancreatic Cancer

Brief Summary

The purpose of the study is selecting second line therapy for patients with pancreatic cancer using molecular profiling will improve 1 year survival.

Detailed Description

Following first-line therapy with a gemcitabine based regimen, a significant number of patients will maintain an adequate performance status and be able to tolerate a second-line therapy. A recent phase III trial randomized patients to either 5-flurouracil (5FU), folinic acid or to the addition of weekly oxaliplatin to the same regimen of 5FU/folinic acid. The interim results showed a statistically significant survival advantage for the oxaliplatin containing arm (26 versus 13 weeks, P= 0.014). However the outcome of patients who have progressed on a first-line gemcitabine regimen is still poor with median survival of about 2-6 months.

Almost all patients with advanced APC, treated with gemcitabine alone or a gemcitabine based combination therapy will exhibit resistance to therapy. In patients treated with gemcitabine alone, the time to progression (TTP) is about 3-4 months. Thus most patients will exhibit progression and /or toxicity and will require second line therapy at 4-6 months into first line therapy. The best one year survival reported in a phase II trial is only 24%. However there is no standard second line therapy for APC, a rapid progression of tumor is seen in this setting, and new strategies based on rational target identification are needed. In this study we propose to select therapy based on the molecular profiling of each patients tumor.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Previously Treated Metastatic Pancreatic Cancer

Intervention ^ICMJE

Drug: Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank

FDA approved drugs as indicated by molecular profiling

Other Name: FDA approved drugs as indicated by molecular profiling

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2012

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

metastatic adenocarcinoma of the pancreas
male or non-pregnant female
18 years of age or greater
one prior therapy for the treatment of metastatic disease
must start continuation therapy within 9 months of starting first line treatment
have adequate organ and bone marrow function
must have a Karnofsky performance status greater than or equal to 70
one or more metastatic tumors measurable by CT scan and accessible for biopsy

Exclusion Criteria:

operable or locally advanced pancreatic cancer
metastatic tumor that is not amendable to biopsy
known brain mets unless previously treated and well controlled
active, uncontrolled bacterial, viral or fungal infections
known infection with HIV, hepatitis B or hepatitis C
pregnant or breast-feeding patients

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01196247

Other Study ID Numbers ^ICMJE

SU2C-001

Has Data Monitoring Committee

Responsible Party

Ramesh Ramanathan, MD, TGen

Study Sponsor ^ICMJE

TGen Drug Development Services

Collaborators ^ICMJE

Scottsdale Healthcare
Stand Up To Cancer
AACR

Investigators ^ICMJE

Principal Investigator:

Ramesh Ramanathan, MD

TGen

Information Provided By

TGen Drug Development Services

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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