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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
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).
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.
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.
Select...
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:Select...
I can swallow normally and my stomach and intestines absorb medications as they should.
Select...
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.
Select...
I am not pregnant or breastfeeding due to the study's risk of birth defects.
Select...
My cancer is not a poorly differentiated neuroendocrine carcinoma.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival (PFS)
Secondary study objectives
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 2021 Phase 3 trial • 693 Patients • NCT0202850763%
Neutrophil count decreased
55%
Fatigue
34%
Hypertension
27%
Mucositis
24%
Nausea
22%
Weight gain
20%
Diarrhea
20%
Arthralgia
19%
Hypothermia
19%
Upper respiratory infection
19%
Weight loss
18%
Vomiting
17%
Headache
15%
Anorexia
15%
Back pain
15%
Constipation
15%
Pruritus
14%
Cough
12%
Dyspepsia
12%
Bone pain
11%
Abdominal pain
11%
Fever
10%
Alopecia
10%
Flu like symptoms
10%
Pain
10%
Hot flashes
8%
Dizziness
8%
Obesity
8%
Pain in extremity
6%
Anemia
6%
Dysgeusia
5%
Palmar-plantar erythrodysesthesia syndrome
5%
Nail disorder
2%
Respiratory infection
1%
Urinary bladder carcinoma
1%
Urinary tract infection
1%
Stroke
1%
Acidosis
1%
Suicide attempt
1%
Bone fracture
1%
Catheter related infection
1%
Dyspnea
1%
Febrile neutropenia
1%
Heart failure
1%
Hematoma
1%
Lymphedema
1%
Non-cardiac chest pain
1%
Pneumonitis
1%
Sepsis
1%
Hip replacement
1%
Tooth infection
1%
Uveitis
1%
Respiratory failure
1%
Hypercalcemia
1%
Bacteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Palbociclib Plus Exemestane
Cohort 1 and 2: Capecitabine
Cohort 2: Palbociclib Plus Fulvestrant
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
13,893 Previous Clinical Trials
41,012,274 Total Patients Enrolled
5 Trials studying Pancreatic Neuroendocrine Carcinoma
1,894 Patients Enrolled for Pancreatic Neuroendocrine Carcinoma
Alliance for Clinical Trials in OncologyLead Sponsor
515 Previous Clinical Trials
219,678 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.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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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