A Phase 1 interventional study of Gemcitabine and nab-paclitaxel in Pancreas Cancer, Pancreatic Cancer and Adenocarcinoma of the Pancreas, sponsored by The Cooper Health System. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by The Cooper Health System · Phase 1, Interventional, and Treatment
This study is looking at determining the maximum safe dose of CyberKnife when given with chemotherapy for unresectable adenocarcinoma of the pancreas.
The purpose of this study is to determine the MTD for radiosurgery in the treatment of unresectable pancreas cancer, this MTD can then be used in future phase II or III studies. In terms of starting dose for the phase I study, based on the low toxicity seen in the Moffitt study we feel that 30 Gy in five fractions will be a successful starting dose.
Most of the data in unresectable is derived from patients in the metastatic setting in terms of chemotherapy agents. There have been two major studies that looked at various chemotherapy regimens versus the previous standard of care Gemzar. One study found improved survival with FOLFIRINOX and a second found that the combination of nab-paclitaxel and gemzar were superior to gemzar alone. Thus, the current standard of care for metastatic pancreas cancer (in which a local therapy like radiation has more limited role) is either FOLFIRINOX or gemzar and nab-paclitaxel. While there is some discussion of a randomized study comparing FOLFIRINOX and gemzar combined with nab-paclitaxel such a study has not started as of this time and it is unclear how much interest there would be in accruing to this study. Therefore the exact best chemotherapy regimen for metastatic disease is unclear but is either FOLFIRIONX or gemzar-nab-paclitaxel. The chemotherapy regimens for unresectable cancer are extrapolated from the metastatic setting, per NCCN guidelines any chemotherapy regimen approved for metastatic disease is reasonable to use in unresectable pancreas cancer. Thus for purpose of this study we have chosen one of the two chemotherapy regimens that have shown the best results in the metastatic setting, since there is no way to determine the exact best regimen we have chosen gemzar and nab-paclitaxel since it is felt that this is a less toxic regimen as compared to FOLFIRINOX.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →The Cooper Health System is the lead sponsor of 67 studies on the registry; 18 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Unresectable disease based on the following imaging criteria (table 1)
Exclusion Criteria:
Chemotherapy: Gemcitabine 1000 mg/m2 and Abraxane 125 mg/m2 weekly x3 of 28 day cycle Radiation: 20-55 GY over 5 fractions Dosing schedule: 3 cycles of chemotherapy, followed by CyberKnife, followed by 3 additional cycles of chemotherapy.
Drug: Gemcitabine · Drug: nab-paclitaxel · Radiation: CyberKnife
Also known as: gemzar
Also known as: abraxane
Also known as: cyber knife, CK, Stereotactic radiosurgery
Maximum tolerable dose
This study is to evaluate the MTD for Cyberknife when given in conjunction with Gemcitabine and Abraxane.
Time frame: 4-7 months
overall survival
Time frame: 6 months, 1 year, 5 years
Tumor response per RECIST 1.1
Time frame: 4 months, 6 months, 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 months, 6 months, 1 year
quality of life
Time frame: 2 months, 4 months, 6 months, 1 year
This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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