A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer
Primary Purpose
Previously Treated Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank
Sponsored by
About this trial
This is an interventional treatment trial for Previously Treated Metastatic Pancreatic Cancer focused on measuring pancreatic cancer, molecular profiling, SU2C, Second line therapy, Stage 4
Eligibility Criteria
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
Sites / Locations
- TGen Clinical Research Services at Scottsdale Healthcare
Outcomes
Primary Outcome Measures
Determine the percent of patients who are alive at one year
Goal is to improve the one year survival (from start of first-line therapy for metastatic disease) to 60%
Secondary Outcome Measures
Full Information
NCT ID
NCT01196247
First Posted
September 3, 2010
Last Updated
July 16, 2012
Sponsor
Translational Drug Development
Collaborators
Scottsdale Healthcare, Stand Up To Cancer, American Association for Cancer Research
1. Study Identification
Unique Protocol Identification Number
NCT01196247
Brief Title
A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer
Official Title
Stand Up to Cancer Consortium: Phase II Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated With Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Translational Drug Development
Collaborators
Scottsdale Healthcare, Stand Up To Cancer, American Association for Cancer Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Previously Treated Metastatic Pancreatic Cancer
Keywords
pancreatic cancer, molecular profiling, SU2C, Second line therapy, Stage 4
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank
Other Intervention Name(s)
FDA approved drugs as indicated by molecular profiling
Intervention Description
FDA approved drugs as indicated by molecular profiling
Primary Outcome Measure Information:
Title
Determine the percent of patients who are alive at one year
Description
Goal is to improve the one year survival (from start of first-line therapy for metastatic disease) to 60%
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesh Ramanathan, MD
Organizational Affiliation
TGen
Official's Role
Principal Investigator
Facility Information:
Facility Name
TGen Clinical Research Services at Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer
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