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New treatment option for Pancreatic Ductal Adenocarcinoma (PDAC)
Official title Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT03977233
What this study is testing
What is Oxaliplatin?
Oxaliplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic ductal adenocarcinoma (pdac).
Also referred to as Eloxatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a research study to evaluate how the genetic makeup of Pancreatic Ductal Adenocarcinoma (PDAC) can affect the response to FDA-approved chemotherapy treatment, FOLFIRINOX, given before surgery to remove the tumor. Certain types of PDAC tumors can be surgically resected (removed).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Histologically or cytologically confirmed adenocarcinoma of the pancreas with no evidence of distant metastatic disease.
- Subject has no evidence of co-morbidities precluding the potential to undergo surgical resection of PDAC as determined by surgical investigator.
- people must be willing to undergo a mandatory pre- and post-treatment EUS guided core biopsy of the pancreatic mass.
- Measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) resectable...
You likely can't join if
- Subject has any evidence of local recurrence or metastatic pancreatic cancer.
- Other malignancies within the past 5 years except for adequately treated cervical or vulvar carcinoma in situ, treated basal cell carcinoma...
- Subject has hypersensitivity to 5FU, oxaliplatin or other platinum agent, or irinotecan or to their excipients.
- Subject has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment. people are not permitted to participate in...
- Subject has current evidence of any condition that makes participating in this study not in the best interest of the subject, including but not...
See the full eligibility criteria
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Histologically or cytologically confirmed adenocarcinoma of the pancreas with no evidence of distant metastatic disease.
- Subject has no evidence of co-morbidities precluding the potential to undergo surgical resection of PDAC as determined by surgical investigator.
- people must be willing to undergo a mandatory pre- and post-treatment EUS guided core biopsy of the pancreatic mass.
- Measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) resectable, borderline resectable or unresectable locally advanced PDAC.
- Subject has adequate performance status as defined by ECOG performance status 0 or 1.
- Subject has received no prior chemotherapy or chemoradiotherapy for pancreatic cancer. people have not previously received surgery to remove pancreatic cancer.
- Age ≥ 18 years of age.
- Subject has adequate organ function at study entry.
- Subject has life expectancy of at least 6 months.
- Subject has any evidence of local recurrence or metastatic pancreatic cancer.
- Other malignancies within the past 5 years except for adequately treated cervical or vulvar carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1).
- Subject has hypersensitivity to 5FU, oxaliplatin or other platinum agent, or irinotecan or to their excipients.
- Subject has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment. people are not permitted to participate in another investigational drug study while being treated on this protocol...
- Subject has current evidence of any condition that makes participating in this study not in the best interest of the subject, including but not limited to:
- Myocardial infarction within the past 6 months
- New York Heart Association (NYHA) Class III or IV heart disease
- Active infection requiring IV antibiotics
- Subject has a history of or suspected Gilbert's syndrome or known homozygosity for UGT1A1\ 28 polymorphism (baseline testing not required).
- Subject has sensory peripheral neuropathy grade ≥ 2.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Subject is unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of phenytoin, carbamazepine, phenobarbital, rifampin and rifabutin is discouraged, but not contraindicated. If people require...
- Subject is pregnant or lactating.
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration...
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.