Pancreas Cancer: Molecular Profiling as a Guide to Therapy Before and After Surgery ("Personalized Medicine")

Phase 2

Completed

Brief Summary: In this clinical trial, if the doctor knows or suspects that a growth in the pancreas is cancer (adenocarcinoma), then a sample of the growth is tested (the test is called molecular profiling). The results of the test are used by the doctor to recommend therapy (chemotherapy and radiation therapy) that the patient will receive before having surgery to remove the adenocarcinoma. When the patient goes to surgery, the adenocarcinoma that is removed is tested again. The results of that test are used to guide the choice of therapy after surgery.

The chemotherapy drugs and the radiation therapy used in this clinical trial are already approved for treatment of pancreas cancer. This trial is intended to establish which treatment is best for a specific patient, based on test results from that patient's actual adenocarcinoma. In the past, the decision as to which treatment the patient will receive was not based on testing of the actual adenocarcinoma.

See treatment pathways at http://www.mcw.edu/surgery/patientinfo/Pancreatic-Cancer-Trial.htm.

Hypothesis: Resectability rate, overall survival rate and progression-free survival in subjects with adenocarcinoma of the pancreas will be superior for who receive targeted "personalized" therapy.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Any patient with one or more of the following will be excluded:

Have received chemotherapy or chemoradiation within 5 years prior of study enrollment
Have any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study enrollment
Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
Known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection
Pregnant or breast-feeding patients or any patient with child-bearing potential not using contraception 4 weeks prior to, during and 4 months after study treatment is discontinued

Primary Outcome Measures

Name	Time	Method
Number of Subjects Completing Therapy Including Surgical Resection.	At time of surgery (approximately 10 to 20 weeks after screening)	This outcome measure is the number of subjects completing therapy up to and including surgical resection. In this context, surgical excision of residual tumor is an option in the progression of usual care. Surgery was contraindicated for some participants. This measure is the number of subject who were eligible for and completed the surgical procedure.

Secondary Outcome Measures

Name	Time	Method
Overall Survival in Months	5 years	This measure is the median time of survival (in months) at five years from the initiation of therapy. Results will be presented for two cohorts: subjects completing neoadjuvant therapy and surgical resection; and subjects completing neoadjuvant therapy but without surgical resection.
Use of Biomarkers to Determine Course of Treatment	Initiation of therapy (approximately 4 to 12 weeks after screening) until surgery (approximately 10 to 20 weeks after screening)	The number of subjects for whom a biomarker (i.e., molecular profile) was used to determine the course of treatment.
Histologic Response to Targeted Chemotherapeutic Regimens in Resected Tumors.	At time of surgery (approximately 10 to 20 weeks after screening)	The number of tumors showing a histologic response. Histological response will be measured using the Ryan Score method as defined by the American Joint Committee on Cancer, 7th edition (see Edge, 2010). Grading categories are defined as: Grade 0 (complete response); Grade 1 (near complete response); Grade 2 (partial response); and Grade 3 (poor or no response).
Progression-free Survival	5 years	This measure is the number of subjects not experiencing tumor progression at five years from initiating therapy.

Locations (2): Froedtert and The Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
University of Cincinnati Cancer Center
🇺🇸
Cincinnati, Ohio, United States