Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pancreas Cancer
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adverse Events
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a prospective, open-label therapeutic interventional investigation designed to interrogate the efficacy and safety of individualized matched therapies in patients with pancreatic cancer at high risk of disease recurrence post-surgery.
Detailed Description
This is a prospective, open-label, therapeutic interventional investigation designed to interrogate the efficacy and safety of personalized matched therapy in pancreatic cancer patients who have completed all intended multimodal therapy, including resection of the pancreatic cancer tumor. Potential participants must have their tumor tissue or blood molecularly profiled with the results discussed by the Molecular Tumor Board, whether convened in person, virtually (e.g., WebEx), or in an electronic forum (e.g., email). Only those patients who agree to receive the Molecular Tumor Board-recommended matched therapy (i.e., study treatment) will be eligible and enrolled on the study.
Investigators
Mandana Kamgar, MD
Assistant Professor
Medical College of Wisconsin
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years.
- •Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).
- •Pancreatic tumor is surgically removed and
- •patient has received multimodal therapy (neoadjuvant, sandwich or adjuvant chemotherapy ± radiation) or
- •patient is ineligible for or refuses multimodal therapy.
- •Patient has one of the following:
- •Post-surgical cancer antigen (CA) 19-9 elevation (\> 35 U/mL at least 6 weeks post-surgical resection) in the setting of bilirubin \< 2 mg/dL (unless bilirubin elevation is consistent with Gilbert's syndrome) OR
- •High-risk pathological features, defined as positive surgical margin or lymph node involvement in cancer.
- •Patient has no definitive measurable disease recurrence or metastatic disease at the time of first post-surgical imaging (in those with high-risk pathological features) or within four weeks of elevated CA 19-9 value as evidenced by appropriate imaging.
- •Laboratory values:
Exclusion Criteria
- •A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- •CA 19-9 non-producers, unless high-risk pathological features present.
- •Receiving concomitant investigational agent(s) for pancreatic ductal adenocarcinoma (PDAC).
- •Radiographic evidence of metastatic disease.
- •Inability to ingest study drugs by mouth.
- •Diarrheal bowel movements \> 6 per day postoperatively on maximal medical therapy.
- •Patient has active, untreated, or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic intravenous therapy.
- •Patient has undergone or planned major surgery other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ) within four weeks prior to Day 1 of study therapy.
- •Patient has a history of allergy or hypersensitivity to the study drug(s) or any of the excipients.
- •Uncontrolled concurrent illness, including, but not limited to, unstable angina pectoris, uncontrolled and clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Outcomes
Primary Outcomes
Adverse Events
Time Frame: Up to 12 months
The number of clinically relevant Grade 3 to 4 adverse events and serious adverse events that are at least possibly related to the study therapy per investigator assessment.
Disease-free Survival
Time Frame: Six months
The number of subjects exhibiting disease-free survival at six months. Disease-free survival is defined as the time from study therapy initiation until disease recurrence or death from any cause.