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Anti-metabolites
Chemotherapy vs Radioactive Drug for Pancreatic Neuroendocrine Tumors
Phase 2
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage: locally unresectable or metastatic disease
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years from randomization
Awards & highlights
Study Summary
This trial is testing two different chemotherapy drugs (capecitabine and temozolomide) against a radioactive drug (lutetium Lu 177 dotatate) to see which is more effective at killing pancreatic neuroendocrine tumor cells in patients with advanced disease.
Who is the study for?
Adults with advanced pancreatic neuroendocrine tumors (well-differentiated G1, G2, or well-differentiated G3) that can't be surgically removed and have spread. Eligible participants may have symptoms from the tumor or hormone excess not controlled by medication, must show tumor growth on scans within the past year, and could have had certain previous treatments but not specific chemotherapy drugs or peptide receptor radionuclide therapy (PRRT).Check my eligibility
What is being tested?
The trial is testing whether a combination of chemotherapy drugs Capecitabine and Temozolomide is more effective than Lutetium Lu 177 Dotatate, a radioactive drug targeting cancer cells while sparing normal ones. Participants will also complete questionnaires to assess their quality of life during treatment.See study design
What are the potential side effects?
Capecitabine and Temozolomide might cause nausea, vomiting, diarrhea, fatigue, hand-foot syndrome (redness/pain in hands/feet), low blood cell counts increasing infection risk. Lutetium Lu 177 Dotatate may lead to nausea, vomiting, temporary hair loss and kidney/liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be removed by surgery or has spread to other parts of my body.
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I am 18 years old or older.
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My cancer has worsened in less than 4 months.
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer can be measured on scans.
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My condition worsened in the last year despite being treated with SSA.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My pancreatic tumor is confirmed to be a well-differentiated neuroendocrine type.
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My cancer is a neuroendocrine tumor that started in my pancreas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years from randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years from randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Change in Overall Health Question (Q29) from the EORTC QLQ-C30 questionnaire
Change in Overall Quality of Life Question (Q30) from the EORTC QLQ-C30 questionnaire
Duration of response
+7 moreSide 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%
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
Group I: Arm II (capecitabin, temozolomide)Experimental Treatment3 Interventions
Patients receive capecitabine PO BID days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 4 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (lutetium Lu 177 dotatate)Experimental Treatment3 Interventions
Patients receive lutetium Lu 177 dotatate IV over 30 minutes on day 1. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Capecitabine
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,656 Total Patients Enrolled
5 Trials studying Pancreatic Neuroendocrine Carcinoma
1,894 Patients Enrolled for Pancreatic Neuroendocrine Carcinoma
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,440 Total Patients Enrolled
Timothy J. b, MDStudy ChairMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with specific cancer drugs like mTOR or VEGF inhibitors.Your albumin level in the blood is at least 3.0 grams per deciliter.I've been on a stable dose of somatostatin analog for 3+ months for my functional tumor and it has grown despite the treatment.Your hemoglobin level is at least 9.0 grams per deciliter.My cancer cannot be removed by surgery or has spread to other parts of my body.I have grade 2 or 3 disease with symptoms like pain or hormone issues not managed by current treatments.I am 18 years old or older.My cancer has worsened in less than 4 months.I can swallow normally and my stomach and intestines absorb medications as they should.I can take care of myself and am up and about more than half of my waking hours.Your platelet count needs to be at least 100,000 per cubic millimeter.My cancer can be measured on scans.My brain metastases are treated, stable, and I've been off treatment for 2 months.Your AST and ALT levels are not more than 3 times the upper limit of normal.My condition worsened in the last year despite being treated with SSA.I've recovered from all side effects of my previous ablation treatment, which was done over 2 months ago.You need to have a certain number of white blood cells called neutrophils in your blood.My bilirubin levels are within the required range.My kidney function, measured by creatinine levels or clearance, is within the required range.My tumor shows positive for somatostatin receptors in recent scans.I've had over 2 treatments for my condition, not counting anti-VEGF therapy, but still have symptoms or hormone issues.My heart condition is stable and not severe.I haven't received specific chemotherapy or targeted therapy for my pancreatic neuroendocrine tumor.I am not pregnant or breastfeeding due to the study's risk of birth defects.My cancer is not a poorly differentiated neuroendocrine carcinoma.I don't have any untreated serious health or mental conditions.My pancreatic tumor is confirmed to be a well-differentiated neuroendocrine type.My cancer is a neuroendocrine tumor that started in my pancreas.I've had treatments including SSA and anti-VEGF or can't take anti-VEGF due to side effects, and my disease has worsened in the last year.My tumor may or may not be affecting organ function.I've had liver artery embolization, recovered, and my cancer progressed after treatment.I have no active cancer except for non-melanoma skin cancer or cervical carcinoma in situ, or I've been free of any other cancer for 3+ years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (lutetium Lu 177 dotatate)
- Group 2: Arm II (capecitabin, temozolomide)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any serious hazards linked to Capecitabine use?
"Our team judged capecitabine to have a safety rating of 2, considering that there is only preliminary clinical evidence for its efficacy and some data indicating it's safe."
Answered by AI
How extensive is the participant base of this research endeavor?
"This clinical study requires the participation of 198 patients that meet a predetermined set of inclusion criteria. O'Fallon, South dakota and Carterville, Pennsylvania are two locales offering this trial to suitable individuals."
Answered by AI
Is recruitment still open for this exploration?
"Affirmative. As per the data provided by clinicaltrials.gov, this medical investigation is currently recruiting patients and was first published on March 16th 2022 with its latest update having occurred on September 25th of the same year. 198 participants are required for completion across 66 distinct sites."
Answered by AI
What is the scope of this experiment's implementation?
"Currently, 66 medical sites are running this trial; there is a location in Carterville, O'Fallon and Pittsburgh among others. For the convenience of participants it's best to select the nearest clinic for minimal travel needs if you decide to join."
Answered by AI
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