Perioperative Therapy for Resectable Pancreatic Cancer

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00609336
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 35
• Location: 1
• Arm: 1
• Duration (Months): 107
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This phase II trial studies how well giving combination chemotherapy together with intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with intensity-modulated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Pancreas; Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer	Drug: gemcitabine hydrochloride; Drug: docetaxel; Drug: capecitabine; Radiation: intensity-modulated radiation therapy; Drug: oxaliplatin; Procedure: pancreatic surgical procedure; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To estimate the median overall survival of patients with adenocarcinoma of the pancreas treated with induction chemotherapy, neoadjuvant chemoradiotherapy, surgical resection and adjuvant chemotherapy.

SECONDARY OBJECTIVES:

1. To determine the percent of patients surviving at annual intervals through five years.

2. To determine the median recurrence free survival following pancreaticoduodenectomy.

3. To determine the clinical response rate to neoadjuvant chemotherapy and chemoradiotherapy.

4. To determine the pathologic response rate to neoadjuvant chemotherapy and chemoradiotherapy.

5. To determine the cancer antigen (CA) 19-9 tumor marker response rate to neoadjuvant chemotherapy and chemoradiotherapy.

6. To determine the surgical completion rate and complication rate following neoadjuvant chemotherapy and chemoradiotherapy.

7. To determine the frequency and severity of toxicities associated with this treatment regimen.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 75 minutes and docetaxel IV over 30 or 60 minutes on days 4 and 11. Patients also receive capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

NEOADJUVANT CHEMORADIOTHERAPY: Beginning no more than 14 days after completion of induction chemotherapy, patients receive capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Patients also undergo IMRT once daily on days 1-5 and 8-13.

SURGICAL RESECTION: Approximately 2-6 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo pancreaticoduodenectomy.

ADJUVANT CHEMOTHERAPY: Beginning 4-10 weeks after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gemcitabine hydrochloride 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.

After completion of study treatment, patients are followed up every 3 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment (chemotherapy, radiation, pancreaticoduodenectomy) See Detailed Description

Drug: gemcitabine hydrochloride; Given IV; Other Names: dFdC difluorodeoxycytidine hydrochloride gemcitabine Gemzar ; Drug: docetaxel; Given IV; Other Names: RP 56976 Taxotere TXT ; Drug: capecitabine; Given PO; Other Names: CAPE Ro 09-1978/000 Xeloda ; Radiation: intensity-modulated radiation therapy; Undergo IMRT; Other Names: IMRT ; Drug: oxaliplatin; Given IV; Other Names: 1-OHP Dacotin Dacplat Eloxatin L-OHP ; Procedure: pancreatic surgical procedure; Undergo pancreaticoduodenectomy; Other Names: pancreatic surgery ; Procedure: therapeutic conventional surgery; Undergo therapeutic conventional surgery; Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. Median Overall Survival of Patients With Adenocarcinoma of the Pancreas [5 years]

   Time at which Kaplan-Meier estimate of overall survival drops below 50%

Secondary Outcome Measures

1. Percent of Patients Surviving at 5 Years [Up to 5 years]

   Kaplan-Meier estimate of overall survival at 5 years

2. Median Recurrence Free Survival Following Pancreaticoduodenectomy [From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years]

   The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.

3. Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy [Up to 7 years]

   Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.

4. Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy [Up to 7 years]

   The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90

5. CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy [Up to 26 weeks after surgery]

   Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.

6. Surgical Completion Rate and Complication Rate [Up to 6 weeks following the completion of chemoradiotherapy]

7. Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [Up to 26 weeks after surgery (the end of adjuvant chemotherapy)]

8. Percent of Patients Surviving at Annual Intervals [5 years]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed diagnosis of localized, resectable or borderline resectable, pancreatic adenocarcinoma T1-T3, N0-N1, M0; stage is determined by helical multi-phase computed tomography (CT) and/or endoscopic ultrasound according to published guidelines; resectability is determined by the treating surgeon and published guidelines (National Comprehensive Cancer Network)

• Resectable Disease- Head/Body/Tail of pancreas:

• No distant metastases

• Clear fat plane around celiac and superior mesenteric arteries (SMA)

• Patent superior mesenteric vein (SMV) and portal vein (PV)

• Borderline Resectable Disease -Head/Body of pancreas:

• Tumor abutment on SMA

• SMV/portal vein impingement or occlusion if involving only a short segment, with open vein both proximally and distally (if proximal vein is occluded up to the portal vein branches then disease is unresectable)

• Colon or mesocolon invasion

• Gastroduodenal artery (GDA) encasement up to origin at hepatic artery

• Tail of pancreas:

• Adrenal, colon or mesocolon, or kidney invasion

• Preoperative evidence of biopsy-positive peripancreatic lymph node

• No prior therapy for pancreatic cancer

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

• Leucocytes >= 3,000/uL

• Absolute Neutrophil Count >= 1,500/uL

• Platelets >= 100,000/uL

• Total Bilirubin:

• If within normal limits (WNL) to =< 2.0, the subject is eligible

• If > 2.0 - < 6.0, subject is eligible IF they have a biliary stent and total bilirubin is decreasing

• If >= 6.0, subject is not eligible

• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal or =< 1.5 X upper limit of normal (ULN) if alkaline phosphatase (Alk Phos) > 2.5 X ULN or if the subject has a biliary stent and the liver function tests (LFTs) are decreasing the subject is eligible

• Creatinine clearance >= 30%

• Negative pregnancy test for women of childbearing potential; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

• Ability to swallow and retain oral medication

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

Exclusion Criteria:

• Patients may not be receiving any other investigational agents

• Histology other than adenocarcinoma

• Patients with permanently unresectable pancreatic adenocarcinoma as determined by the treating physician and published guidelines (National Comprehensive Cancer Network)

• Unresectable disease

• Head of pancreas:

• Distant metastases (includes celiac and/or para-aortic)

• SMA, celiac encasement

• SMV/portal occlusion

• Aortic, inferior vena cava (IVC) invasion or encasement

• Invasion of SMV below transverse mesocolon

• Body of pancreas:

• Distant metastases (includes celiac and/or para-aortic); at the discretion of the treating surgeon, body and tail lesions that have positive celiac and/or para-aortic nodes in close vicinity to the primary may be borderline rather than unresectable

• SMA, celiac, hepatic encasement

• SMV/portal extended occlusion

• Aortic invasion

• Tail of pancreas:

• Distant metastases (includes celiac and/or para-aortic)

• SMA, celiac encasement

• Rib, vertebral invasion

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, docetaxel, capecitabine, oxaliplatin or other agents used in the study

• Patients who have received prior chemotherapy or radiotherapy for the diagnosis of pancreatic cancer

• 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

• Inability to comply with study and/or follow-up procedures

• Pregnancy or lactation

• Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington	United States	98109

Sponsors and Collaborators

• University of Washington
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Andrew Coveler, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrew Coveler, Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT00609336
• Other Study ID Numbers: 6511; NCI-2010-00553; 6511; P30CA015704
• First Posted: Feb 7, 2008
• Last Update Posted: Jul 13, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Adenocarcinoma; Pancreatic Neoplasms; Gemcitabine; Capecitabine; Docetaxel; Oxaliplatin

Study Results

Participant Flow

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery gemcitabine: Given IV oxaliplatin: Given IV
Period Title: Overall Study
STARTED	35
Surgery	22
COMPLETED	22
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery laboratory biomarker analysis: Correlative studies
Overall Participants	32
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62
Sex: Female, Male (Count of Participants)
Female	15 46.9%
Male	17 53.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	30 93.8%
Unknown or Not Reported	2 6.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 3.1%
Asian	1 3.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	30 93.8%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
Description	Time at which Kaplan-Meier estimate of overall survival drops below 50%
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

All eligible patients

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery laboratory biomarker analysis: Correlative studies
Measure Participants	32
Median (95% Confidence Interval) [months]	31.6

2. Secondary Outcome

Title	Percent of Patients Surviving at 5 Years
Description	Kaplan-Meier estimate of overall survival at 5 years
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

all eligible patients

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery laboratory biomarker analysis: Correlative studies
Measure Participants	32
Number [percentage of eligible pts alive]	31.6

3. Secondary Outcome

Title	Median Recurrence Free Survival Following Pancreaticoduodenectomy
Description	The appearance of radiographic findings consistent with recurrent tumor at the local resection site or at a distant location is considered a radiographic recurrence.
Time Frame	From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years

Outcome Measure Data

Analysis Population Description

Among eligible patients who received surgery

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery laboratory biomarker analysis: Correlative studies
Measure Participants	22
Median (95% Confidence Interval) [months]	31.3

4. Secondary Outcome

Title	Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy
Description	Assessed using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Time Frame	Up to 7 years

Outcome Measure Data

Analysis Population Description

Clinical response not collected.

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery laboratory biomarker analysis: Correlative studies
Measure Participants	0

5. Secondary Outcome

Title	Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy
Description	The resected pancreaticoduodenectomy specimen and accompanying lymph nodes will be staged according to American Joint Committee on Cancer 6th Edition incorporating the prefix y to indicate a specimen status-post neoadjuvant treatment (ypTNM). Cancer 2012;118:1382-90
Time Frame	Up to 7 years

Outcome Measure Data

Analysis Population Description

all eligible patients with non-missing data

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery laboratory biomarker analysis: Correlative studies
Measure Participants	22
Count of Participants [Participants]	20 62.5%

6. Secondary Outcome

Title	CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy
Description	Biochemical response is a decrease of >= 50% of CA 19-9 serum tumor marker in patients with elevated CA 19-9 at baseline.
Time Frame	Up to 26 weeks after surgery

Outcome Measure Data

Analysis Population Description

Biomarker data not collected.

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery laboratory biomarker analysis: Correlative studies
Measure Participants	0

7. Secondary Outcome

Title	Surgical Completion Rate and Complication Rate
Time Frame	Up to 6 weeks following the completion of chemoradiotherapy

Outcome Measure Data

Analysis Population Description

all eligible patients

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery laboratory biomarker analysis: Correlative studies
Measure Participants	32
Completion rate	22 68.8%
Complication rate	2 6.3%

8. Secondary Outcome

Title	Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time Frame	Up to 26 weeks after surgery (the end of adjuvant chemotherapy)

Outcome Measure Data

Analysis Population Description

All eligible patients

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery laboratory biomarker analysis: Correlative studies
Measure Participants	32
Any Grade 2 CTCAE toxicity	21
Any Grade 3 CTCAE toxicity	121
Any Grade 4 CTCAE toxicity	14

9. Secondary Outcome

Title	Percent of Patients Surviving at Annual Intervals
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery gemcitabine: Given IV oxaliplatin: Given IV
Measure Participants	32
Year 1	81 253.1%
Year 2	62 193.8%
Year 3	45 140.6%
Year 4	37 115.6%
Year 5	31 96.9%

Adverse Events

Arm/Group Title	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
Arm/Group Description	See Detailed Description gemcitabine hydrochloride: Given IV docetaxel: Given IV capecitabine: Given PO intensity-modulated radiation therapy: Undergo IMRT oxaliplatin: Given IV pancreatic surgical procedure: Undergo pancreaticoduodenectomy therapeutic conventional surgery: Undergo therapeutic conventional surgery gemcitabine: Given IV oxaliplatin: Given IV
All Cause Mortality
	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
	Affected / at Risk (%)	# Events
Total	32/35 (91.4%)
Blood and lymphatic system disorders
Anemia	6/35 (17.1%)	9
Fever, Neutropenic	3/35 (8.6%)	3
Neutropenia	24/35 (68.6%)	31
Thrombocytopenia	10/35 (28.6%)	12
Thrombotic Microangiopathy	1/35 (2.9%)	1
Cardiac disorders
Atrial Fibrillation	1/35 (2.9%)	1
Myocardial Infarction	1/35 (2.9%)	2
Transient Ischemic Attacks	1/35 (2.9%)	1
Gastrointestinal disorders
Diarrhea	5/35 (14.3%)	5
Nausea	3/35 (8.6%)	3
Vomiting	2/35 (5.7%)	2
Entero Cutaneous Fistula	1/35 (2.9%)	1
Lower GI Bleed	1/35 (2.9%)	1
Odynophagia	1/35 (2.9%)	1
General disorders
Fatigue	4/35 (11.4%)	4
Shoulder Pain	1/35 (2.9%)	1
Hepatobiliary disorders
Cholangitis	1/35 (2.9%)	1
Cholangitis With Stent Occlusion	1/35 (2.9%)	1
Cholecystic Abcess	1/35 (2.9%)	1
Intrahepatic Absesses	1/35 (2.9%)	1
Non-Malignant Ascitess	1/35 (2.9%)	1
Obstructive Jaundice	1/35 (2.9%)	1
Portal Vein Thrombosis	1/35 (2.9%)	1
Transaminitis	1/35 (2.9%)	1
Infections and infestations
Infection	1/35 (2.9%)	2
Bacterial Sepsis	1/35 (2.9%)	1
Urinary tract infection	2/35 (5.7%)	2
Investigations
Elevated Bilirubin	4/35 (11.4%)	4
Metabolism and nutrition disorders
Anorexia	1/35 (2.9%)	1
Dehydration	1/35 (2.9%)	1
Hypoalbuminemia	1/35 (2.9%)	1
Hypoatremic	1/35 (2.9%)	1
Hyponatremia	1/35 (2.9%)	1
Nervous system disorders
Syncope	1/35 (2.9%)	1
Respiratory, thoracic and mediastinal disorders
Mucositis	3/35 (8.6%)	3
Pneumonitis	1/35 (2.9%)	1
Nose Bleeds	1/35 (2.9%)	1
Skin and subcutaneous tissue disorders
Hand-foot Syndrome	20/35 (57.1%)	22
Anasarca	1/35 (2.9%)	1
Pruritus	1/35 (2.9%)	1
Vascular disorders
Hypertension	2/35 (5.7%)	3
Hypotension	2/35 (5.7%)	2
Other (Not Including Serious) Adverse Events
	Treatment (Chemotherapy, Radiation, Pancreaticoduodenectomy)
	Affected / at Risk (%)	# Events
Total	14/32 (43.8%)
Blood and lymphatic system disorders
Neutropenia	3/32 (9.4%)	3
Thrombocytopenia	2/32 (6.3%)	2
Gastrointestinal disorders
Vomiting	1/32 (3.1%)	1
Hepatobiliary disorders
Cholangitis	1/32 (3.1%)	1
Transaminase	1/32 (3.1%)	1
Infections and infestations
Infection	1/32 (3.1%)	1
Investigations
Elevated Bilirubin	1/32 (3.1%)	1
Respiratory, thoracic and mediastinal disorders
Maculopapular Rash	1/32 (3.1%)	1
Skin and subcutaneous tissue disorders
Hand Foot Syndrome	7/32 (21.9%)	8
Maculopapular Rash	1/32 (3.1%)	1
Rash - Upper Torso	1/32 (3.1%)	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.