Exceptional Responders With Pancreatic Cancer to Chemotherapy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | September 2018 |
| Contact: | Mark J Ricigliano, DVM, PhD |
| Email: | mark.ricigliano@verizon.net |
| Phone: | 301-317-7160 |
Evaluation of Exceptional Responders With Pancreatic Cancer to Standard of Care Chemotherapy
This is an observational study enrolling patients with metastatic pancreatic cancer to
identify genomic differences between exceptional responder and non-responders to standard of
care chemotherapy. Data analysis of the gene expression profile of the exceptional
responders compared to non-responders will define genomic patterns that may help understand
their response to chemotherapy.
identify genomic differences between exceptional responder and non-responders to standard of
care chemotherapy. Data analysis of the gene expression profile of the exceptional
responders compared to non-responders will define genomic patterns that may help understand
their response to chemotherapy.
This is an observational study of patients with metastatic pancreatic cancer to identify
genomic differences obtained from their circulating tumor cells between exceptional
responders and non-responders to standard of care chemotherapy. This study requires a 10 mL
heparinized peripheral blood sample from each study participant at the time of enrollment to
isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression
profile will define genomic patterns using Nearest Template Prediction for a predetermined
panel of therapeutic agents based on standard of care. Chemotherapy selection is
physician-choice. Information regarding disease progression will be gathered. Data analysis
will be performed in study participants in the setting of ongoing disease progression.
genomic differences obtained from their circulating tumor cells between exceptional
responders and non-responders to standard of care chemotherapy. This study requires a 10 mL
heparinized peripheral blood sample from each study participant at the time of enrollment to
isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression
profile will define genomic patterns using Nearest Template Prediction for a predetermined
panel of therapeutic agents based on standard of care. Chemotherapy selection is
physician-choice. Information regarding disease progression will be gathered. Data analysis
will be performed in study participants in the setting of ongoing disease progression.
Inclusion Criteria:
- Histological or cytological confirmation of metastatic pancreatic adenocarcinoma.
- Patient is treatment-naïve or currently receiving front-line chemotherapy with
FOLFIRINOX or GEMCITABINE-ABRAXANE and has stable disease.
- ECOG performance status 0-2.
- Patients must have a hemoglobin of 7.5 g/dl or greater and be hemodynamically stable
and/or physiologically compensated for their anemia
Exclusion Criteria:
- HIV positive on antiretroviral therapy
- Disease progression following front-line chemotherapy
- Pregnant or lactating
- Prior organ allograft
- Any medical or psychiatric condition that may interfere with the ability to comply
with protocol treatment
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