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Predicting Effective Therapy in 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: NCT03033927
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.

Condition or disease Intervention/treatment
Pancreatic Cancer Pancreatic Adenocarcinoma Diagnostic Test: CTC isolocation and analysis

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : January 24, 2020
Estimated Study Completion Date : January 24, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants with Stage IV Pancreatic Cancer Diagnostic Test: CTC isolocation and analysis
Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 36 months ]
    in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis


Biospecimen Retention:   Samples With DNA

Sodium heparin tube collections will be performed at baseline, at each restaging CT scan and at time of first disease progression. K3-EDTA tubes will be collected at baseline and at disease progression.

In patients who are planning an EGD for the purpose of obtaining a tumor biopsy, portal vein sampling will be offered. Under EUS guidance, a 19-gauge EUS fine needle will be advanced transhepatically into the portal vein and as many as four 7.5 mL K3-EDTA samples of blood will be aspirated, as previously described. Research biopsy will be performed at baseline and, if feasible, at disease progression.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with advanced pancreatic adenocarcinoma.
Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC, AJCC stage IV disease at time of enrollment.
  • Patient planning to receive treatment with FOLFIRINOX or gem/nab-P chemotherapy, with or without investigational agents.
  • Prior surgery, chemotherapy and/or radiation therapy for AJCC Stage I-III pancreatic adenocarcinoma is permitted.
  • ECOG performance status 0-2.
  • A minimum age of 18 years old.

Exclusion Criteria:

  • Prior chemotherapy for AJCC stage IV pancreatic adenocarcinoma
  • Known to be HIV positive on antiretroviral therapy
  • Prior organ allograft
  • Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

Information from the National Library of Medicine

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): NCT03033927


Contacts
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Contact: Kenneth Yu, M.D. 646-888-4188 yuk1@mskcc.org
Contact: Eileen O'Reilly, MD 646-888-4182

Locations
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United States, New Jersey
Memoral Sloan Kettering Cancer Center Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Kenneth Yu, MD    646-888-4188      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Kenneth Yu, MD    646-888-4188      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Kenneth Yu, MD    646-888-4188      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Kenneth Yu, MD    646-888-4188      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03033927     History of Changes
Other Study ID Numbers: 17-042
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Stage IV Pancreatic Cancer
FOLFIRINOX
gem/nab-P chemotherapy
17-042
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases