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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
Must not have
No known medical condition causing an inability to swallow and no known impairment of gastrointestinal function that may significantly alter the absorption of an oral agent
No uncontrolled congestive heart failure (New York Heart Association [NYHA] II, III, IV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years from randomization
Awards & highlights

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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can swallow normally and my stomach and intestines absorb medications as they should.
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My heart condition is stable and not severe.
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I haven't received specific chemotherapy or targeted therapy for my pancreatic neuroendocrine tumor.
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I am not pregnant or breastfeeding due to the study's risk of birth defects.
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My cancer is not a poorly differentiated neuroendocrine carcinoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years from randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years from randomization for reporting.

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 more

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%
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%
Aspartate Aminotransferase Increased
21%
Chills
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Cough
13%
Abdominal Pain Upper
13%
Hypomagnesaemia
13%
Blood Creatinine Increased
13%
Hyperbilirubinaemia
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Influenza like illness
8%
Gamma-glutamyltransferase increased
8%
Paraesthesia
8%
Dysphonia
8%
Malaise
8%
Faeces discolored
8%
International normalised ratio increased
8%
Hypoaesthesia
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
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
13,748 Previous Clinical Trials
40,959,203 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
217,428 Total Patients Enrolled
Timothy J. b, MDStudy ChairMayo Clinic

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05247905 — Phase 2
Pancreatic Neuroendocrine Carcinoma Research Study Groups: Arm I (lutetium Lu 177 dotatate), Arm II (capecitabin, temozolomide)
Pancreatic Neuroendocrine Carcinoma Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT05247905 — Phase 2
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05247905 — Phase 2
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