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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:
Translational Drug Development
ClinicalTrials.gov Identifier:
NCT01196247
First received: September 3, 2010
Last updated: July 16, 2012
Last verified: July 2012

September 3, 2010
July 16, 2012
September 2010
November 2011   (final data collection date for primary outcome measure)
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%
Same as current
Complete list of historical versions of study NCT01196247 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer
Stand Up to Cancer Consortium: Phase II Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated With Metastatic Pancreatic Cancer

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Previously Treated Metastatic Pancreatic Cancer
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
February 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01196247
SU2C-001
No
Ramesh Ramanathan, MD, TGen
Translational Drug Development
  • Scottsdale Healthcare
  • Stand Up To Cancer
  • AACR
Principal Investigator: Ramesh Ramanathan, MD TGen
Translational Drug Development
July 2012

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