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Chemotherapy for Pancreatic Cancer

Phase 2
Recruiting
Led By Heloisa P Soares
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gastrointestinal bleed
Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of registration to date of death due to any cause, assessed up to 5 years
Awards & highlights

Study Summary

This trial looks at giving capecitabine & temozolomide after surgery to patients with a certain kind of pancreatic tumor. These drugs work in different ways to stop the growth of tumor cells. This could prevent or delay the return of cancer in these patients.

Who is the study for?
This trial is for adults who've had surgery for high-risk, well-differentiated pancreatic neuroendocrine tumors. They must be able to swallow pills, have no other active cancers (with some exceptions), and not have received certain treatments post-surgery. A complete medical history and physical exam are required, along with specific blood count and chemistry levels.Check my eligibility
What is being tested?
The trial tests the effectiveness of two chemotherapy drugs, capecitabine and temozolomide, given after surgery to prevent cancer from returning in patients with high-risk pancreatic neuroendocrine tumors. The study will observe how these drugs stop tumor cells from growing or spreading.See study design
What are the potential side effects?
Capecitabine may cause side effects like diarrhea, hand-foot syndrome (redness/pain/swelling of hands/feet), nausea, vomiting; while temozolomide can lead to fatigue, headache, constipation/diarrhea. Both drugs might also lower blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had bleeding in my stomach or intestines.
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I've had a recent scan showing no signs of cancer spread.
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I have a blockage in my digestive tract.
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I am 18 years old or older.
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My surgery removed all visible cancer, or nearly all.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I experienced pain from my tumor before it was surgically removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to date of death due to any cause, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration to date of death due to any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence-free survival (RFS)
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)

Side effects data

From 2020 Phase 2 & 3 trial • 151 Patients • NCT03093870
63%
Nausea
58%
Fatigue
54%
Diarrhoea
50%
Decreased Appetite
46%
Vomiting
42%
Pyrexia
42%
Hypokalaemia
38%
Abdominal Pain
33%
Constipation
33%
Blood Bilirubin Increased
29%
Abdominal Distension
29%
Hyponatraemia
29%
Dizziness
29%
Oedema Peripheral
29%
Back Pain
25%
Hypotension
25%
Stomatitis
25%
Palmar-plantar Erythrodysaethesia Syndrome
25%
Dehydration
25%
Anaemia
21%
Aspartate Aminotransferase Increased
21%
Dyspnoea
21%
Chills
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Hyperbilirubinaemia
13%
Cough
13%
Abdominal Pain Upper
13%
Blood Creatinine Increased
13%
Hypomagnesaemia
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Depression
8%
Gastrooesophageal Reflux Disease
8%
Gamma-glutamyltransferase increased
8%
International normalised ratio increased
8%
Paraesthesia
8%
Influenza like illness
8%
Dysphonia
8%
Malaise
8%
Hypoaesthesia
8%
Faeces discolored
8%
Hypoglycemia
8%
Acute Kidney Injury
8%
Enterocolitis
8%
Hematemesis
8%
Hyperkalaemia
8%
Hypocalcaemia
8%
Blood alkaline phosphatase increased
8%
Epistaxis
8%
Bile duct obstruction
8%
Oral pain
8%
Neutrophil Count Decreased
8%
Myalgia
8%
Insomnia
8%
Early satiety
8%
Rhinitis allergic
8%
Bursitis
8%
Musculoskeletal pain
8%
Anxiety
8%
Dysgeusia
8%
Acute kidney injury
8%
Cholangitis
4%
Cardiac arrest
4%
Rash generalized
4%
Respiratory Failure
4%
Septic shock
4%
Small intestinal obstruction
4%
Spinal cord compression
4%
Toxic leukoencephalopathy
4%
Peripheral Sensory Neuropathy
4%
Haematemesis
4%
Hypercalcaemia
4%
Hyponatremia
4%
Hypoxic-ischaemic encephalopathy
4%
Ischaemic stroke
4%
Lung Infection
4%
Metabolic acidosis
4%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo and Capecitabine - Part 1
Varlitinib and Capecitabine - Safety Lead-In
Varlitinib and Capecitabine - Part 1

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (capecitabine, temozolomide)Experimental Treatment2 Interventions
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO once QD on days 10-14. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (surveillance)Active Control1 Intervention
Patients undergo surveillance with no active treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Capecitabine
2013
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,029 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,670 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,713 Total Patients Enrolled

Media Library

Capecitabine Clinical Trial Eligibility Overview. Trial Name: NCT05040360 — Phase 2
Pancreatic Neuroendocrine Tumors Research Study Groups: Arm I (capecitabine, temozolomide), Arm II (surveillance)
Pancreatic Neuroendocrine Tumors Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT05040360 — Phase 2
Capecitabine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05040360 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for new patients in this research project?

"This study is currently recruiting participants, as indicated on clinicaltrials.gov. The trial was originally posted on October 14th, 2021 and was last updated on December 3rd, 2021."

Answered by AI

Are there potentially fatal side effects to taking Capecitabine?

"While there is some data suggesting capecitabine is safe, as this is only a Phase 2 trial, there is no clinical evidence yet to support its efficacy. Consequently, it received a score of 2."

Answered by AI

What are some other research projects that have used Capecitabine?

"As of now, there are 561 total trials regarding Capecitabine with 153 being in the third stage. Although many studies for this treatment are based in Woolloongabba, Queensland, there are a whopping 16764 locations running clinical trials for it."

Answered by AI

How many people can join this research project?

"That is correct. The clinical trial, which began recruitment on October 14th 2021, is still looking for patients. There have been no changes to the 6 participating sites or the 141 patient goal since December 3rd 2021."

Answered by AI

For what purpose is Capecitabine most often prescribed?

"Capecitabine is a medication that can be used to manage progression, disease. It has also been shown to help patients with nitrosourea treatment, advance directives, and refractory, advanced mycosis fungoides."

Answered by AI

Is this an innovative clinical trial?

"There are 561 ongoing studies for the medication Capecitabine in 70 different countries. The first study was held 18 years ago and involved 60 patients. It completed Phase 2 of testing in 2002 and was sponsored by Schering-Plough. Since that time, 843 total studies have been completed."

Answered by AI

At how many hospitals is this research being conducted?

"There are six medical centers participating in this study, located in Ames, Fort Dodge, Boone, and other cities."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
UC Irvine Health/Chao Family Comprehensive Cancer Center
University of Michigan Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
2022. "Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05040360.
All > Neuroendocrine Tumor
~46 spots leftby Mar 2025
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