Pre-operative Treatment for Patients With Untreated Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03138720|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Resectable Pancreatic Cancer Unresectable Pancreatic Cancer Pancreatic Adenocarcinoma Neoadjuvant Pancreatic Cancer||Drug: Paclitaxel Protein Bound (Abraxane)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||There will be two treatment groups: those who are deemed resectable and those that are deemed borderline resectable and with locally advanced pancreas cancer.|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Official Title:||A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Paricalcitol as Pre-operative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas|
|Actual Study Start Date :||May 23, 2017|
|Estimated Primary Completion Date :||December 15, 2019|
|Estimated Study Completion Date :||March 1, 2020|
Experimental: Open Label
All patients will receive open label medication at set dosages unless the dosage needs to be adjusted to treat an adverse event or dose toxicity.
Drug: Paclitaxel Protein Bound (Abraxane)
Participants will be treated with the regimen prior to having surgery. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization. If CA19-9 is normalized, then participant will be scheduled for surgery and moved to standard of care. If CA19-9 is not normalized then participants will complete another 3 cycles.
- CA19-9 value [ Time Frame: approximately 63 days ]Laboratory testing will be used to determine if the CA19-9 value has normalized after 3 cycles of treatment.
- Pathologic Complete Response Rate [ Time Frame: approximately 63 days ]Participants will have an MRI completed after 3 cycles to determine if the tumor has responded to treatment. RECIST 1.1 criteria will be used to evaluate response. A confirmatory PET scan may be ordered to confirm complete response.
- Overall Survival [ Time Frame: every 12 weeks after study completion ]Participants will be contacted by telephone every 12 weeks until date of death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138720
|Contact: Brandy Carothersfirstname.lastname@example.org|
|Contact: Andrea Brooksemail@example.com|
|United States, Arizona|
|HonorHealth Research Institute||Recruiting|
|Scottsdale, Arizona, United States, 85258|
|Contact: Joyce Schaffer, MSN, AOCNS 480-323-1339 ext option #2 Joyce.Schaffer@HonorHealth.com|
|Principal Investigator: Erkut Borazanci, MD|
|Principal Investigator:||Erkut Borazanci, MD||HonorHealth Research Institute|