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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 belowSelect...
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.
Select...
I have a blockage in my digestive tract.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of registration to date of death due to any cause, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of registration to date of death due to any cause, assessed up to 5 years
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 • NCT0309387063%
Nausea
58%
Fatigue
54%
Diarrhoea
50%
Decreased Appetite
46%
Vomiting
42%
Pyrexia
42%
Hypokalaemia
38%
Abdominal Pain
33%
Blood Bilirubin Increased
33%
Constipation
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%
Dyspnoea
21%
Chills
21%
Aspartate Aminotransferase Increased
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Cough
13%
Hypomagnesaemia
13%
Blood Creatinine Increased
13%
Hyperbilirubinaemia
13%
Abdominal Pain Upper
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Influenza like illness
8%
Hypoaesthesia
8%
Gamma-glutamyltransferase increased
8%
Paraesthesia
8%
Faeces discolored
8%
Dysphonia
8%
International normalised ratio increased
8%
Malaise
8%
Gastrooesophageal Reflux Disease
8%
Depression
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
264,479 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,120 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,728 Previous Clinical Trials
40,965,867 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have cancer spread to my brain or its coverings.I have no allergies to medications similar to temozolomide or capecitabine.I do not have problems absorbing medications.I am not planning to take warfarin during the treatment.I have had bleeding in my stomach or intestines.I do not have any ongoing or uncontrolled infections.Participants must have specific levels of blood cells and chemicals in their blood.I do not have untreated metastatic cancer.I have not had pre-surgery treatment for pancreatic neuroendocrine tumor, but may have used somatostatin analogs.I've had a recent scan showing no signs of cancer spread.I have no other active cancers or a history of cancer, except for certain exceptions.I have a blockage in my digestive tract.I am 18 years old or older.I have not had a heart attack or stroke in the last year.My surgery removed all visible cancer, or nearly all.I've had a full medical check-up in the last 28 days.If you have pancreatic neuroendocrine tumors that have been surgically removed, you need to have a Zaidi score of 3 or higher based on certain factors and points.I have recovered from any surgery effects, as confirmed by my doctor.I had surgery or ablation for up to 5 liver metastases during my pancreatic NET surgery.I can take care of myself and am up and about more than 50% of my waking hours.I can swallow pills.My Ki-67 test result is between 3% and 55%, done within the last 14 to 90 days.I can undergo CT or MR imaging with contrast agents as needed.I experienced pain from my tumor before it was surgically removed.My tumor causes symptoms.I haven't taken somatostatin analogs after my surgery.I had surgery to remove a well-differentiated pancreatic tumor between 14 and 90 days ago.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (capecitabine, temozolomide)
- Group 2: Arm II (surveillance)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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