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.

Study Overview

• Status: Completed
• Conditions: Previously Treated Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank

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: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • TGen Clinical Research Services at Scottsdale Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	One year

Collaborators and Investigators

• Sponsor: Translational Drug Development
• Collaborators: Stand Up To Cancer; American Association for Cancer Research; Scottsdale Healthcare
• Investigators: Principal Investigator: Ramesh Ramanathan, MD, TGen

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 7, 2010
• First Posted (Estimate): September 8, 2010

Study Record Updates

• Last Update Posted (Estimate): July 17, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: pancreatic cancer; molecular profiling; Stage 4; Second line therapy; SU2C
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: SU2C-001