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

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ClinicalTrials.gov Identifier: NCT01196247
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : July 17, 2012
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Previously Treated Metastatic Pancreatic Cancer Drug: Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2010
Primary Completion Date : November 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. Determine the percent of patients who are alive at one year [ Time Frame: One year ]
    Goal is to improve the one year survival (from start of first-line therapy for metastatic disease) to 60%

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196247

United States, Arizona
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
Translational Drug Development
Scottsdale Healthcare
Stand Up To Cancer
American Association for Cancer Research
Principal Investigator: Ramesh Ramanathan, MD TGen
More Information

Responsible Party: Ramesh Ramanathan, MD, TGen
ClinicalTrials.gov Identifier: NCT01196247     History of Changes
Other Study ID Numbers: SU2C-001
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by Translational Drug Development:
pancreatic cancer
molecular profiling
Second line therapy
Stage 4

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases