Capecitabine for Pancreas

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pancreas+5 More
Capecitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Metastatic Pancreatic Neuroendocrine Tumor
  • Pancreas

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to 8 years from randomization

Year 2
Progression Free Survival (PFS) at 2 years
Year 3
Progression Free Survival (PFS) at 3 years
Month 18
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
Year 8
Duration of response
Incidence of adverse events
Objective response rate (ORR)
Progression free survival (PFS)
Time to progression (TTP)
Time-to response
Year 8
Overall survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Varlitinib and Capecitabine - Part 1
52%Nausea
44%Blood Bilirubin Increased
41%Diarrhoea
39%Decreased Appetite
34%Vomiting
31%Palmar-plantar Erythrodysaethesia Syndrome
25%Abdominal Pain
25%Fatigue
23%Pyrexia
23%Blood Creatinine Increased
20%Anaemia
17%Asthenia
17%Pruritus
16%Alanine Aminotransferase Increased
14%Constipation
14%Aspartate Aminotransferase Increased
13%Malaise
13%Platelet Count Decreased
13%Rash
11%Stomatitis
11%Dyspepsia
11%Hyperbilirubinaemia
9%Hypoalbuminaemia
9%Chills
8%Dysgeusia
8%Mucosal Inflammation
8%Dyspnoea
8%Cholangitis
8%Pneumonia
8%Peripheral Sensory Neuropathy
8%Acute Kidney Injury
8%Skin Hyperpigmentation
8%Blood bilirubin increased
6%Back Pain
6%Hyponatraemia
6%Abdominal Distension
6%Hypotension
6%Oedema Peripheral
6%Cough
6%Dizziness
5%Hypoglycemia
5%Abdominal Pain Upper
5%Neutrophil Count Decreased
5%Gastrooesophageal Reflux Disease
5%Weight Decreased
5%Insomnia
5%Proteinuria
5%Myalgia
5%Ascites
3%Bile duct obstruction
3%Disease progression
3%Hyperkalaemia
3%Hypokalaemia
3%Musculoskeletal pain
3%Hypocalcaemia
3%Epistaxis
3%Acute kidney injury
3%Blood alkaline phosphatase increased
2%Small intestinal haemorrhage
2%Hypomagnesaemia
2%Jaundice cholestatic
2%International normalised ratio increased
2%Pain
2%Hepatobiliary infection
2%Anemia
2%Decreased appetite
2%Blood creatinine increased
2%Erythema multiforme
2%Biliary sepsis
2%Biliary tract infection
2%Intestinal obstruction
2%Cholangiolitis
2%Liver abscess
2%Biloma
2%Dry mouth
2%Oral pain
2%Gamma-glutamyltransferase increased
2%Paraesthesia
2%Muscular weakness
2%Oedema peripheral
2%Cholecystitis
2%Jaundice
2%General physical health deterioration
2%Urinary tract infection
2%Dyspnoea exertional
2%Blood culture positive
2%Anxiety
This histogram enumerates side effects from a completed 2020 Phase 2 & 3 trial (NCT03093870) in the Varlitinib and Capecitabine - Part 1 ARM group. Side effects include: Nausea with 52%, Blood Bilirubin Increased with 44%, Diarrhoea with 41%, Decreased Appetite with 39%, Vomiting with 34%.

Trial Design

2 Treatment Groups

Arm I (lutetium Lu 177 dotatate)
1 of 2
Arm II (capecitabin, temozolomide)
1 of 2

Experimental Treatment

198 Total Participants · 2 Treatment Groups

Primary Treatment: Capecitabine · No Placebo Group · Phase 2

Arm I (lutetium Lu 177 dotatate)Experimental Group · 3 Interventions: Quality-of-Life Assessment, Lutetium Lu 177 Dotatate, Questionnaire Administration · Intervention Types: Other, Drug, Other
Arm II (capecitabin, temozolomide)Experimental Group · 3 Interventions: Temozolomide, Quality-of-Life Assessment, Capecitabine · Intervention Types: Drug, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~2700
Capecitabine
2002
Completed Phase 3
~3010

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 years from randomization

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,000 Previous Clinical Trials
41,300,709 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
498 Previous Clinical Trials
214,548 Total Patients Enrolled
Timothy J. b, MDStudy ChairMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a tumor that is not functional or nonfunctional.
You have locally unresectable or metastatic disease.
Patients previously treated with SSA only and with disease progression by RECIST in prior 12 months.
SSTR positivity is defined as uptake greater than background liver in all measurable lesions.
You have previously been treated with SSA for up to 2 months for symptoms of disease bulk causing pain, anorexia, early satiety, large effusions/ascites, abdominal pain, abdominal fullness due to hepatomegaly, dyspnea, and/or diarrhea
You have disease progression by RECIST criteria in < 4 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.