Pancreatic Adenocarcinoma, Pancreatic Cancer
Conditions
Keywords
Stage IV Pancreatic Cancer, FOLFIRINOX, gem/nab-P chemotherapy, 17-042
Brief summary
The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.
Interventions
DIAGNOSTIC_TESTCTC isolocation and analysis
Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 36 months | in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis |
Countries
United States
Outcome results
None listed