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

Previously Treated Metastatic Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196247
• Other study ID #: SU2C-001
• Status: Completed
• Phase: Phase 2
• First received: September 3, 2010
• Last updated: July 16, 2012
• Start date: September 2010
• Est. completion date: February 2012

Study information

• Verified date: July 2012
• Source: Translational Drug Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Previously Treated Metastatic Pancreatic Cancer

Intervention

Drug:
• Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank
FDA approved drugs as indicated by molecular profiling

Locations

Country	Name	City	State
United States	TGen Clinical Research Services at Scottsdale Healthcare	Scottsdale	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Translational Drug Development	American Association for Cancer Research, Scottsdale Healthcare, Stand Up To Cancer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No