A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer
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Purpose
The purpose of the study is selecting second line therapy for patients with pancreatic cancer using molecular profiling will improve 1 year survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Previously Treated Metastatic Pancreatic Cancer |
Drug: Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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%
| Enrollment: | 35 |
| Study Start Date: | September 2010 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
-
Drug: Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, Arizona | |
| TGen Clinical Research Services at Scottsdale Healthcare | |
| Scottsdale, Arizona, United States, 85258 | |
| Principal Investigator: | Ramesh Ramanathan, MD | TGen |
More Information
No publications provided
| Responsible Party: | Ramesh Ramanathan, MD, TGen |
| ClinicalTrials.gov Identifier: | NCT01196247 History of Changes |
| Other Study ID Numbers: | SU2C-001 |
| Study First Received: | September 3, 2010 |
| Last Updated: | July 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by TGen Drug Development Services:
|
pancreatic cancer molecular profiling SU2C Second line therapy Stage 4 |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013