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Using gemcitabine and nab-paclitaxel, the investigators hope to establish the differential ability of local and cytologically positive disease to respond to this regimen, and in particular, the frequency of cytologic conversion from positive to negative in such patients. The investigators also can begin to assess the value of maximum local therapy, including surgery, in patients who cytologically convert from positive to negative.
This research study is a Phase Ib clinical trial. It will assess the frequency of cytological conversion in patients with pancreatic adenocarcinoma and positive peritoneal cytology as a sole metastatic site following gemcitabine nab-paclitaxel.
Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer with positive peritoneal cytology as a sole metastatic site and meet all inclusion/exclusion criteria.
Treatment consists of 4 week treatment cycles. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine and Nab-Paclitaxel | Experimental | Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Administered by intravenous infusion over 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of cytological conversion | To assess the frequency of cytological conversion in patients with pancreatic adenocarcinoma and positive peritoneal cytology as a sole metastatic site following gemcitabine nab-paclitaxel. | An average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Assess progression-free survival (PFS) | Up to 5 years |
| Overall survival (OS) | Assess overall survival (OS). |
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Inclusion Criteria:
Male, or a non-pregnant and non-lactating female.
Age ≥ 18 years.
Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC).
Radiographic and pathologic staging (including staging laparoscopy with peritoneal wash) consistent with pancreatic cancer, resectable, borderline resectable, or locally advanced or unresectable as defined by NCCN guidelines (http://www.nccn.org/professionals/physician\_gls/f\_guidelines.asp).
Laparoscopic confirmation that the PDAC is localized except for positive peritoneal cytology. Biliary stents are permitted.
Elevated CA19-9.
Measurable disease as defined by RECIST 1.1.
ECOG performance status of ≤ 1 (see Appendix A).
Adequate bone marrow reserves as evidenced by:
Adequate hepatic function as evidenced by:
Adequate renal function as evidenced by creatinine ≤1.5 x ULN.
Women of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/nab-paclitaxel and for 3 months following the last dose of gemcitabine/nab- paclitaxel, even if he has undergone a successful vasectomy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent J Picozzi, MD | Contact | 206-223-6193 | Vincent.Picozzi@virginiamason.org |
| Name | Affiliation | Role |
|---|---|---|
| Vincent J Picozzi, MD | Virginia mason medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia mason medical Center | Recruiting | Seattle | Washington | 98101 | United States |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| nab-paclitaxel | Drug | Administered by intravenous infusion over 30-40 minutes. |
|
|
| Up to 5 years |
| Overall response rate | Assess overall response rate. | Up to 5 years |
| Response rate by CA19-9 | Assess response rate as measured by serial CA19-9 determinations. | An average of 1 year |
| Response rate by RECIST criteria 1.1 | Assess response rate as measured by RECIST criteria 1.1 radiographic criteria. | Assessment approximately every 8 weeks during treatment up to 5 years |
| Ability to achieve R0 (complete) | Assess the ability to achieve R0 (complete) resection rate in anatomically appropriate patients. | At time of surgery, approximately 6 months after enrollment |
| Local disease control rate. | Measure the local disease control rate. | Baseline, and approximately every 8 weeks during treatment. Up to 5 years |
| Pattern of disease recurrence | Observe the pattern of disease recurrence (both in anatomic space and time) in the above patient population. | Up to 5 years |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |