Stand Up to Cancer Consortium: Phase II Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated With Metastatic Pancreatic Cancer
18 Years
N/A
Both
Previously Treated Metastatic Pancreatic Cancer
Trial Information
Stand Up to Cancer Consortium: Phase II Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated With Metastatic Pancreatic Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the percent of patients who are alive at one year
Outcome Description:
Goal is to improve the one year survival (from start of first-line therapy for metastatic disease) to 60%
Outcome Time Frame:
One year
Safety Issue:
No
Principal Investigator
Ramesh Ramanathan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
TGen
Authority:
United States: Institutional Review Board
Study ID:
SU2C-001
NCT ID:
NCT01196247
Start Date:
September 2010
Completion Date:
February 2012
Related Keywords:
- Previously Treated Metastatic Pancreatic Cancer
- pancreatic cancer
- molecular profiling
- SU2C
- Second line therapy
- Stage 4
- Pancreatic Neoplasms
Name | Location |
|---|---|
| TGen Clinical Research Services at Scottsdale Healthcare | Scottsdale, Arizona 85258 |
