Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02427841
• Collaborator: Oregon Health and Science University (Other), Celgene Corporation (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 73.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride followed by radiation therapy before surgery work in treating patients with pancreatic cancer that can be removed by surgery. Chemotherapy drugs, such as nab-paclitaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel, gemcitabine hydrochloride, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Adenocarcinoma; Resectable Pancreatic Carcinoma	Drug: Fluorouracil; Drug: Gemcitabine; Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Drug: Nab-paclitaxel; Procedure: Therapeutic Conventional Surgery	Phase 2

Detailed Description

PRIMARY OBJECTIVE:

1. To determine the R0 (complete resection) resection rate for subjects with borderline resectable or lymph node positive pancreatic adenocarcinoma treated with a multimodality neoadjuvant therapy of preoperative gemcitabine (gemcitabine hydrochloride) and ABRAXANE (nab-paclitaxel) followed by 5-fluorouracil (fluorouracil) based image-guided intensity-modulated radiation therapy (IG-IMRT) chemoradiotherapy.

SECONDARY OBJECTIVES:

1. To determine 1-year relapse-free survival rate with the investigational protocol.

2. To determine 1-year and 2-year overall survival rates. III. To assess response rate by imaging (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and pathologic analysis.

3. To assess the toxicity and safety according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) criteria.

OUTLINE:

PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel intravenously (IV) over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks.

SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation.

POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks for 1 year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Study of Preoperative Chemotherapy With Abraxane and Gemcitabine Followed by Chemoradiation for Borderline Resectable or Node-Positive Pancreatic Cancer
• Actual Study Start Date: Jan 21, 2016
• Actual Primary Completion Date: Nov 12, 2019
• Anticipated Study Completion Date: Mar 12, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment (chemotherapy, chemoradiation therapy, surgery) PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity.

Drug: Fluorouracil; Given IV; Other Names: 5-Fluoro-2,4(1H, 3H)-pyrimidinedione 5-Fluorouracil 5-Fluracil 5-FU AccuSite Carac Fluoro Uracil Fluouracil Flurablastin Fluracedyl Fluracil Fluril Fluroblastin Ribofluor Ro 2-9757 Ro-2-9757 ; Drug: Gemcitabine; Given IV; Other Names: dFdCyd Difluorodeoxycytidine Gemzar LY-188011 LY188011 ; Radiation: Image Guided Radiation Therapy; Undergo IG-IMRT; Other Names: IGRT image-guided radiation therapy ; Radiation: Intensity-Modulated Radiation Therapy; Undergo IG-IMRT; Other Names: IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy ; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Nab-paclitaxel; Given IV; Other Names: ABI 007 ABI-007 Abraxane Albumin-bound Paclitaxel Albumin-Stabilized Nanoparticle Paclitaxel Nanoparticle Albumin-bound Paclitaxel nanoparticle paclitaxel paclitaxel albumin-stabilized nanoparticle formulation protein-bound paclitaxel ; Procedure: Therapeutic Conventional Surgery; Undergo surgery

Outcome Measures

Primary Outcome Measures

1. R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment [At the time of surgery]

   The R0 resection rate will be computed with 95% confidence interval. A 2-sided binomial test will be used to determine whether the R0 resection rate is significantly greater than 0.37 at 10% significance level.

Secondary Outcome Measures

1. Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 [Up to 5 years]

   Frequency and severity of adverse events will be tabulated based on the actual treatment and the number of courses the patient receives. In particular, grade 3 and 4 toxicity rates will be computed and summarized for all patients received at least one dose of the assigned treatment.

2. Overall Survival Defined as the Percentage of Subjects Alive at the 2 Year Time Point [At 2 years]

   The expected 2-year overall survival rate will be reported with an associated 95% confidence interval. In addition, the overall survival function will be estimated and displayed using a Kaplan Meier curve. The median overall survival will also be estimated with an associated 95% confidence interval.

3. Overall Survival Defined as the Percentage of Subjects Alive at the One Year Time Point [At 1 year]

   The expected 1-year overall survival rate will be reported with an associated 95% confidence interval. In addition, the overall survival function will be estimated and displayed using a Kaplan Meier curve. The median overall survival will also be estimated with an associated 95% confidence interval.

4. Relapse-free Survival Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor [At 1 year]

   The expected 1-year relapse-free survival rate will be reported with an associated 95% confidence interval. In addition, the relapse-free survival function will be estimated and displayed using a Kaplan Meier curve. The median relapse-free survival will also be estimated with an associated 95% confidence interval.

5. Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Number of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT) [After completion of neoadjuvant chemoradiotherapy]

   The expected pathologic response rate will be computed with the associated 95% confidence interval using binomial exact method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must have histologically or cytologically confirmed adenocarcinoma of the pancreas

• Tumors must be localized (non-metastatic) and classified as borderline resectable according to Americas Hepato-Pancreato-Biliary Association (AHPBA)/Society of Surgical Oncology (SSO)/Society for Surgery of the Alimentary Tract (SSAT) consensus criteria or be clinically node-positive via computed tomography (CT) or endoscopic ultrasound

• AHPBA/SSO/SSAT criteria (any one of the following):

• Tumor-associated deformity of the SMV (superior mesenteric vein) or PV (portal vein)

• Abutment of the SMV or PV >= 180 degrees

• Short-segment occlusion of the SMV or PV amenable to resection and venous reconstruction

• Short-segment involvement of the hepatic artery or its branches amenable to resection and reconstruction

• Abutment of the superior mesenteric artery (SMA) < 180 degrees

• Subjects must have measurable disease (by RECIST 1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan

• No prior therapy for pancreatic cancer, including chemotherapy, radiation therapy, definitive surgery or investigational therapy

• Members of all races and ethnic groups will be included

• Eastern Cooperative Oncology Group (ECOG) performance status =< 1

• Absolute neutrophil count >= 1.5 K/cu mm

• Platelets >= 100 K/cu mm

• Hemoglobin >= 9.0 g/dL

• Total bilirubin =< 1.25 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal

• Creatinine within normal institutional limits or creatinine clearance >= 60 mL/min

• No active prior malignancy within 3 years of registration (with the exception of non-melanoma skin cancer, in-situ cancers, or Rai stage 0 chronic lymphocytic leukemia [CLL]); if patient is disease free from a prior malignancy between 3-5 years, special consideration can be requested; in these cases, if the risk of recurrence at 5 years is less than 20%, and in the opinion of the investigator the prior malignancy will not affect the patient's outcome in light of newly diagnosed pancreatic cancer, the patient may be eligible; this will require principle investigator (PI) review and approval on a case by case basis, and approval will be documented in the medical record; all patients who have been disease free from a prior malignancy for at least 5 years will be eligible

• No baseline peripheral sensory neuropathy >= grade 2

• Women of child-bearing potential and men must be willing to use adequate contraception during the entire study and for 8 weeks following completion of all chemotherapy on study; this includes hormonal or barrier method, or abstinence

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Subjects with locally advanced, unresectable primary tumors will not be eligible

• This includes any of the following:

• Abutment of the SMA >= 180 degrees

• Occlusion of the SMV or PV with insufficient normal vein above and below with which to perform venous reconstruction

• Involvement of the hepatic artery with insufficient artery proximal and distal to perform reconstruction

• Any prior therapy (chemotherapy, radiation or surgery) for pancreatic adenocarcinoma other than biliary decompression

• Subjects who are receiving any other investigational agents

• Subjects with known metastases

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABRAXANE or other agents used in the study

• Active infection requiring intravenous antibiotics at the time of registration

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• History of interstitial lung disease, idiopathic pulmonary fibrosis, silicosis, sarcoidosis or connective tissue disorders (including rheumatoid arthritis and systemic lupus erythematosus)

• Pregnant or breastfeeding women are excluded from this study

• Subjects known to be human immunodeficiency virus (HIV)-positive, including those on combination antiretroviral therapy, are ineligible because of the potential for pharmacokinetic interactions with chemotherapy; in addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy

• Subjects with plastic biliary stents will be excluded; metal biliary stents are allowed and will not be excluded

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OHSU Knight Cancer Institute	Portland	Oregon	United States	97239

Sponsors and Collaborators

• OHSU Knight Cancer Institute
• Oregon Health and Science University
• Celgene Corporation

Investigators

• Principal Investigator: Gina Vaccaro, OHSU Knight Cancer Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 24, 2020

More Information

Publications

None provided.

• Responsible Party: Gina Vaccaro, Principal Investigator, OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT02427841
• Other Study ID Numbers: IRB00011256; NCI-2015-00498; SOL-14124-L; IRB00011256
• First Posted: Apr 28, 2015
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Pancreatic Neoplasms; Gemcitabine; Paclitaxel; Albumin-Bound Paclitaxel; Fluorouracil

Study Results

Participant Flow

Pre-assignment Detail	20 participants enrolled who agreed to participate in the study following completion of the informed consent process. 19 started is the number of participants who were assigned to each Arm/Group. One subject withdrew prior to treatment resulting in a total of 19 subjects enrolled and started treatment.

Arm/Group Title	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)
Arm/Group Description	PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Period Title: Overall Study
STARTED	19
COMPLETED	11
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)
Arm/Group Description	PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Overall Participants	19
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 26.3%
>=65 years	14 73.7%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	68
Sex: Female, Male (Count of Participants)
Female	10 52.6%
Male	9 47.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 15.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 5.3%
White	15 78.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	19 100%
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (Count of Participants)
0: Fully Active	3 15.8%
1: Restricted in physically strenuous activity but ambulatory and able to carry out light work	16 84.2%
Primary tumor site (Count of Participants)
Head	11 57.9%
Body or neck	5 26.3%
Tail	3 15.8%
Greatest Tumor diameter (cm) [Median (Full Range) ]
Median (Full Range) [cm]	4.0
Vascular involvement (Count of Participants)
Both arterial and venous	10 52.6%
Arterial only	6 31.6%
Venous only	1 5.3%
No vascular involvement	2 10.5%
Lymph node status (Count of Participants)
Positive nodes on CT scan	13 68.4%
Negative nodes on CT scan	6 31.6%
Serum CA 19-9 (U/mL) [Median (Full Range) ]
Median (Full Range) [U/mL]	231

Outcome Measures

1. Primary Outcome

Title	R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment
Description	The R0 resection rate will be computed with 95% confidence interval. A 2-sided binomial test will be used to determine whether the R0 resection rate is significantly greater than 0.37 at 10% significance level.
Time Frame	At the time of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)
Arm/Group Description	PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
Measure Participants	11
Count of Participants [Participants]	8 42.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.018
	Comments	Standard R0 rate is 37%.
	Method	2-sided binomial
	Comments

2. Secondary Outcome

Title	Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0
Description	Frequency and severity of adverse events will be tabulated based on the actual treatment and the number of courses the patient receives. In particular, grade 3 and 4 toxicity rates will be computed and summarized for all patients received at least one dose of the assigned treatment.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Overall Survival Defined as the Percentage of Subjects Alive at the 2 Year Time Point
Description	The expected 2-year overall survival rate will be reported with an associated 95% confidence interval. In addition, the overall survival function will be estimated and displayed using a Kaplan Meier curve. The median overall survival will also be estimated with an associated 95% confidence interval.
Time Frame	At 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Overall Survival Defined as the Percentage of Subjects Alive at the One Year Time Point
Description	The expected 1-year overall survival rate will be reported with an associated 95% confidence interval. In addition, the overall survival function will be estimated and displayed using a Kaplan Meier curve. The median overall survival will also be estimated with an associated 95% confidence interval.
Time Frame	At 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Relapse-free Survival Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor
Description	The expected 1-year relapse-free survival rate will be reported with an associated 95% confidence interval. In addition, the relapse-free survival function will be estimated and displayed using a Kaplan Meier curve. The median relapse-free survival will also be estimated with an associated 95% confidence interval.
Time Frame	At 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Number of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT)
Description	The expected pathologic response rate will be computed with the associated 95% confidence interval using binomial exact method.
Time Frame	After completion of neoadjuvant chemoradiotherapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse event data was collected at each investigator office visit from start to conclusion of subject's trial period. (up to 5 years). Utilizing NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0).
Adverse Event Reporting Description	Regular investigator assessment.
Arm/Group Title	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)
Arm/Group Description	PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Gemcitabine: Given IV Image Guided Radiation Therapy: Undergo IG-IMRT Intensity-Modulated Radiation Therapy: Undergo IG-IMRT Laboratory Biomarker Analysis: Correlative studies Nab-paclitaxel: Given IV Therapeutic Conventional Surgery: Undergo surgery
All Cause Mortality
	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Serious Adverse Events
	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)
	Affected / at Risk (%)	# Events
Total	3/19 (15.8%)
General disorders
Intractable Nausea, vomiting, abdominal pain	1/19 (5.3%)	1
Dehydration	1/19 (5.3%)	1
Infections and infestations
Abdominal wall soft tissue infection	1/19 (5.3%)	1
Surgical and medical procedures
Fascial Dehiscene	1/19 (5.3%)	1
Vascular disorders
GDA Bleed/Cardiac arrest	1/19 (5.3%)	1
Other (Not Including Serious) Adverse Events
	Treatment (Chemotherapy, Chemoradiation Therapy, Surgery)
	Affected / at Risk (%)	# Events
Total	16/19 (84.2%)
Blood and lymphatic system disorders
Hypokalemia	1/19 (5.3%)	1
Portal vein thrombosis	1/19 (5.3%)	1
General disorders
Elevated liver function tests	1/19 (5.3%)	1
Abdominal pain	1/19 (5.3%)	1
Flank pain	1/19 (5.3%)	1
Fatigue	1/19 (5.3%)	1
Immune system disorders
Neutropenia	6/19 (31.6%)	6
Febrile neutropenia	2/19 (10.5%)	2
Infections and infestations
Sepsis	1/19 (5.3%)	1
Nervous system disorders
Encephalopathy	1/19 (5.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.